Anesthesiology
Review Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Neurological 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
- JAXPneumotachometer2Product Code
- JEZMonitor, Lung Water Measurement3Product Code
- KLKMonitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia2Product Code
- K003943MICROGAS 7650 TRANSCUTANEOUS MONITOR2Cleared 510(K)
- K991644MICROGAS 7650 TRANSCUTANEOUS MONITOR2Cleared 510(K)
- K980287SIEMENS SC9000/SC9015 TCP02/C02 MODULE2Cleared 510(K)
- K924709SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE2Cleared 510(K)
- K924679OXYCARE(TM) OXYGEN CONTROLLER/MONITOR2Cleared 510(K)
- K925910HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULE2Cleared 510(K)
- K893133HORIZON 2110/HORIZON 2210 264-XXX-XXX/261-XXX-XXX2Cleared 510(K)
- K870805MODEL 840 TRANSCUTAN. OXYGEN/CARBON DIOX. MONITOR2Cleared 510(K)
- K861861515A NEO-TRAK NEONATAL MONITOR2Cleared 510(K)
- K860124HORIZON 2000 TRANSCUTANEOUS GAS MONITORING2Cleared 510(K)
- K860951KONTRON CUTANEOUS PO2 MONITOR 8202Cleared 510(K)
- K852959PO-510 TCPO2 MONITOR2Cleared 510(K)
- K851451STAT GAS MODULE2Cleared 510(K)
- K844253NOVAMETRIX 811 TRANSCO2M PORTABLE TRANSCUTANEOUS 22Cleared 510(K)
- K844079NOVAMETRIX 860 PROTA. TRANSCUTANEOUS OXYGEN2Cleared 510(K)
- K842497SERVOMED OXYMONITO SMK 3632Cleared 510(K)
- K842374NOVAMETRIX 850 TRANSCUTANEOUS OXYGEN2Cleared 510(K)
- K840993TRANSCUTANEOUS 800-OXYGEN MONITORS/8012Cleared 510(K)
- K840919DAYPAK SYS VII CATHETER CARE KIT2Cleared 510(K)
- K840918MICRO SPAN TRANSCUTANEOUS OXYGEN MONIT2Cleared 510(K)
- K831319PATIENT MONITOR #4042Cleared 510(K)
- K834057IL 301 PORTABLE TRANSCUT. OXYGEN MONI2Cleared 510(K)
- K832652OXY MONITOR 5-RANGE DUAL-THERMISTOR2Cleared 510(K)
- K830197TRANSCUTANEOUS BLOOD OXYGEN SENSOR SYS2Cleared 510(K)
- K831744TRANSCUTANEOUS OXYGEN MONITOR OPTION2Cleared 510(K)
- K831460AS 30/TCP MODULE2Cleared 510(K)
- K822328IL 301 TRANSCUTANEOUS OXYGEN MONITOR2Cleared 510(K)
- K821936CRITIKON OXYGEN MONITOR, MODEL 80302Cleared 510(K)
- K813350NOVAMETRIX MODEL 807 TRANSCUT. MONITOR2Cleared 510(K)
- K813347CRITIKON TRANSCUTANEOUS GAS MONITORS2Cleared 510(K)
- K813352NOVAMETRIX MODEL 816A TRANSCUT. OXYGEN2Cleared 510(K)
- K813351NOVAMETRIX NAVAGRAPH MODEL 312 RECORDER2Cleared 510(K)
- K812167MODEL 78850 OXYGEN MONITOR2Cleared 510(K)
- K811836PO-200 BLOOD OXYGEN MONITOR2Cleared 510(K)
- K810999CORDIS TCPO2 TRANCUTANEOUS OXYGEN PRESS2Cleared 510(K)
- K811470LIFESPAN 1002Cleared 510(K)
- K802978TRANSCUTANEOUS BLOOD OXYGEN MONITOR #3002Cleared 510(K)
- K802846TCM202 TCPO2 & TCM204 TCPO2/PO2 REC. SY.2Cleared 510(K)
- K800988NOVAMETRIX TCOMETTE #809 TRANS. MONITOR2Cleared 510(K)
- K800631OXYMETER2Cleared 510(K)
- K791559ROCHE SENSOR ADAPTOR2Cleared 510(K)
- K792011TC02M PRECISION GAS CALIBRATOR2Cleared 510(K)
- K792010TC02M ELECTRODE ADHESIVE RINGS2Cleared 510(K)
- K792009TC02 M OXYGEN ELECTRODE CONTACT2Cleared 510(K)
- K791152TCO2M MODEL 8182Cleared 510(K)
- K781910MONITOR, SENSOMATIII OXYGEN2Cleared 510(K)
- K780458TRANSCUTANEOUS OXYGEN PERFUSION MONITOR2Cleared 510(K)
- 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
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
OXYMETER
- Page Type
- Cleared 510(K)
- 510(k) Number
- K800631
- 510(k) Type
- Traditional
- Applicant
- DRAGERWERK AG
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/2/1980
- Days to Decision
- 13 days