Anesthesiology
Review Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Monitoring DevicesCFR Sub-Part
- BXHGauge, Gas Pressure, Cylinder/Pipeline1Product Code
- BXMStimulator, Nerve, Ac-Powered2Product Code
- BXNStimulator, Nerve, Battery-Powered2Product Code
- BXOTransducer, Gas Pressure1Product Code
- BXPTransducer, Gas Flow1Product Code
- BXXCalibrator, Pressure, Gas1Product Code
- BXYFlowmeter, Calibration, Gas1Product Code
- BYMTube, Thorpe, Uncompensated1Product Code
- BYRTransducer, Gas Pressure, Differential1Product Code
- BZQMonitor, Breathing Frequency2Product Code
- CANRegulator, Pressure, Gas Cylinder1Product Code
- CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)2Product Code
- CAXFlowmeter, Tube, Thorpe, Back-Pressure Compensated1Product Code
- CBAMonitor, Air Embolism, Ultrasonic2Product Code
- CCNFlowmeter, Nonback-Pressure Compensated, Bourdon Gauge1Product Code
- ECXCylinder, Compressed Gas, And Valve1Product Code
- FLSMonitor, Apnea, Facility Use2Product Code
- K011597SMARTMONITOR 2, MODEL 40002Cleared 510(K)
- K991087HANNAH WIRELESS VITAL SIGNS MONITOR2Cleared 510(K)
- K962865REMBRANDT SYSTEM2Cleared 510(K)
- K951246PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONS2Cleared 510(K)
- K894973RESPITRACE PLUS2Cleared 510(K)
- K832999RESPIRATION MONITOR2Cleared 510(K)
- K830778MONITORING KIT AMK-12Cleared 510(K)
- K822077RESPIRATION MONITOR TYPE MR-102Cleared 510(K)
- K821721CLINICAL DATA APNEA DETECTOR2Cleared 510(K)
- K820943SYSTEM I INFANT MONITORING SYS2Cleared 510(K)
Show All 16 Submissions
- JAXPneumotachometer2Product Code
- JEZMonitor, Lung Water Measurement3Product Code
- KLKMonitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia2Product Code
- KOIStimulator, Nerve, Peripheral, Electric2Product Code
- LKDMonitor, Carbon-Dioxide, Cutaneous2Product Code
- LPPMonitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia2Product Code
- MNRVentilatory Effort Recorder2Product Code
- MRPAnalyzer, Nitric Oxide2Product Code
- MRQAnalyzer, Nitrogen Dioxide2Product Code
- NPFMonitor, Apnea, Home Use2Product Code
- PRKDevice Indicating An Exhalation Event2Product Code
- PUGAnalyzer, Nitrogen Dioxide, Exempt2Product Code
- PXEPressure Monitoring (Air/Gas) Kit1Product Code
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—MiscellaneousCFR Sub-Part
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SYSTEM I INFANT MONITORING SYS
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K820943
- 510(k) Type
- Traditional
- Applicant
- BURR ENGINEERING & DEVELOPMENT CO.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/3/1982
- Days to Decision
- 27 days