Spacelabs Healthcare

Address: 5150 220th Ave. S.E, Issaquah, Washington 98027, USA
Phone: +1-(425)-657-7200 | Fax: +1-(425)-657-7212 | Map/Directions >>

Profile: Spacelabs Medical renders patient monitoring systems and easy-to-use monitors. We offer products like anaesthesia delivery & ventilation, diagnostic cardiology, patient monitoring & connectivity & clinical education. Our ABP monitors are available with advanced reporting software that allows rapid analysis of patient information. Our digital transmitters are compact, lightweight and water resistant. Our model 90239A ambulatory blood pressure report generator/printer gives a simple, cost-effective method for analyzing data from the recorders.

The company was founded in 1958, has revenues of USD 100-500 Million.

FDA Registration Number: 3023361

37 Products/Services (Click for related suppliers)  
• AC-Powered Tonometer (FDA Code: HKX / 886.1930)
A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.
• Ambulatory Blood Pressure Monitoring
• Ambulatory BP Monitors
• Ambulatory Electrocardiograph (FDA Code: MWJ / 870.2800)
A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.
• Anesthesia Gas-Machine (FDA Code: BSZ / 868.5160)
A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply.
• Arrhythmia Detector and Alarm (FDA Code: DSI / 870.1025)
The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.
• Blood Pressure Computer (FDA Code: DSK / 870.1110)
A blood pressure computer is a device that accepts the electrical signal from a blood pressure transducer amplifier and indicates the systolic, diastolic, or mean pressure based on the input signal.
• Cardiac Monitor (Cardiotachometer and Rate Alarm) (FDA Code: DRT / 870.2300)
A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.
• Clinical Trial Monitoring Service
• Continuous Electronic Thermometer (FDA Code: FLL / 880.2910)
A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.
• Continuous Ventilator (FDA Code: CBK / 868.5895)
A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.
• Ear Oximeter (FDA Code: DPZ / 870.2710)
An ear oximeter is an extravascular device used to transmit light at a known wavelength(s) through blood in the ear. The amount of reflected or scattered light as indicated by this device is used to measure the blood oxygen saturation.
• Ecg Analysis System (FDA Code: LOS)
• ECG Interpretation Computer
• Electrocardiograph (FDA Code: DPS / 870.2340)
An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.
• Electrocardiograph Transmitter/Receiver System (FDA Code: DXH / 870.2920)
A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.
• Electroencephalographs (FDA Code: GWQ / 882.1400)
An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.
• Gaseous Phase Carbon-Dioxide Gas Analyzer (FDA Code: CCK / 868.1400)
A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.
• Gaseous Phase Nitrous-Oxide Gas Analyzer (FDA Code: CBR / 868.1700)
A nitrous oxide gas analyzer is a device intended to measure the concentration of nitrous oxide anesthetic in a gas mixture. The device may use techniques such as infrared absorption or mass spectrometry.
• Gaseous Phase Oxygen Gas Analyzer (FDA Code: CCL / 868.1720)
An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also includes paramagnetic analyzers.
• Holter Monitoring
• Medical Cathode-Ray Tube Display (FDA Code: DXJ / 870.2450)
A medical cathode-ray tube display is a device designed primarily to display selected biological signals. This device often incorporates special display features unique to a specific biological signal.
• Medical Computer and Software (FDA Code: LNX)
• Medical Magnetic Tape Recorder (FDA Code: DSH / 870.2800)
• Non-Heated Anesthesia Vaporizer (FDA Code: CAD / 868.5880)
An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.
• Non-Invasive Blood-Pressure Measurement System (FDA Code: DXN / 870.1130)
A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.
• Oximeters (FDA Code: DQA / 870.2700)
An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.
• Patient Monitoring Systems
• Patient Physiological Monitor (FDA Code: MHX / 870.1025)
• Perinatal Monitoring System (FDA Code: HGM / 884.2740)
A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.
• Physiological Monitors Network and Communication System (FDA Code: MSX / 870.2300)
• Programmable Diagnostic Computer (FDA Code: DQK / 870.1425)
A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.
• Radiofrequency Physiological Transmitter/Receiver System (FDA Code: DRG / 870.2910)
A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.
• Radiological Digital Image Communication System (FDA Code: LMD / 892.2020)
A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, interfaces, and a communications protocol.
• Single-Function Pre-Programmed Diagnostic Computer (FDA Code: DXG / 870.1435)
A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.
• Telemetry Systems
• Ventilatory Effort Recorder (FDA Code: MNR / 868.2375)
A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in 868.2377.

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