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
- 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
- K232516Sentec Digital Monitoring System (SDMS) tCOM+2Cleared 510(K)
- K151329SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet2Cleared 510(K)
- K131253PERIFLUX 60002Cleared 510(K)
- K110474PHILIPS INTELLIVUE TCG102Cleared 510(K)
- K101690SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE2Cleared 510(K)
- K093154TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM2Cleared 510(K)
- K043357TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 52020092Cleared 510(K)
- K043003TCM40 MONITORING SYSTEM2Cleared 510(K)
- K041548SENTEC DIGITAL MONITOR MODEL #SDM2Cleared 510(K)
- K990960PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040)2Cleared 510(K)
- K980756COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE2Cleared 510(K)
- P810037KONTRON KOLORMON PLUS BLOODGAS MODULE 72675052PMA Approval
- P810037KONTRON CUTANEOUS PCO2 MONITOR2PMA Approval
- K913013TCPO2 9260 MODULE - SYSTEM ATHENA2Cleared 510(K)
- K905225HBO CABLE ASSEMBLY, RADIOMETER TC-022Cleared 510(K)
- K900333E5280 COMBINED TRANSCUTANEOUS TCP02/TCPCO2 ELECT.2Cleared 510(K)
- K891481SIEMENS SIRECUST TRANSCUTANEOUS CARBON DIOXIDE2Cleared 510(K)
- K890517TRANSCUTANEOUS O2/CO2 MONITOR2Cleared 510(K)
- K883606MODEL HP 15209A TRANS. COMBINED TCP02/TCPCO2 TRANS2Cleared 510(K)
- P830008CUTANIOUS GAS MONITOR2PMA Approval
- P810022TCO2M MODEL 818 MONITOR2PMA Approval
- P810022TCO2M MODEL 818 MONITOR2PMA Approval
- P840037MODEL 515 NEONATAL MONIOTR2PMA Approval
- P850087LITTON TRANSCUTANEOUS CO2 SYSTEM2PMA Approval
- P810022TCO2M MODEL 818 MONITOR2PMA Approval
- P820019LIFESPAN(TM) 100 TCPCO2 MONITOR2PMA Approval
- P800043RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO2PMA Approval
- P820019LIFESPAN(TM) 100 TCPCO2 MONITOR2PMA Approval
- P810022TCO2M MODEL 818 MONITOR2PMA Approval
- P820019LIFESPAN(TM) 100 TCPCO2 MONITOR2PMA Approval
- P810037KONTRON CUTANEOUS PCO2 MONITOR2PMA Approval
- P810037KONTRON CUTANEOUS PCO2 MONITOR2PMA Approval
- P810022TCO2M MODEL 818 MONITOR2PMA Approval
- P810037KONTRON CUTANEOUS PCO2 MONITOR2PMA Approval
- P820019LIFESPAN(TM) MODEL 4110 TCPO2/CO2 MONITORING SYSTE2PMA Approval
- P810022TCO2M MODEL 818 MONITOR2PMA Approval
- P810022TCO2M MODEL 818 MONITOR2PMA Approval
- P800043RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO2PMA Approval
- P810037KONTRON CUTANEOUS PCO2 MONITOR2PMA Approval
- P830008CUTANIOUS GAS MONITOR2PMA Approval
- P810022TCO2M MODEL 818 MONITOR2PMA Approval
- P830008CUTANIOUS GAS MONITOR2PMA Approval
- P810022TCO2M MODEL 818 MONITOR2PMA Approval
- P810022TCO2M MODEL 818 MONITOR2PMA Approval
- P810022TCO2M MODEL 818 MONITOR2PMA Approval
- P810022TCO2M MODEL 818 MONITOR2PMA Approval
- P820025TCPCO2 MONITORING SYSTEM2PMA Approval
- P800043RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO2PMA Approval
- P820019LIFESPAN(TM) 100 TCPCO2 MONITOR2PMA Approval
- P810037KONTRON CUTANEOUS PCO2 MONITOR2PMA Approval
- P810037KONTRON CUTANEOUS PCO2 MONITOR2PMA Approval
- P810022TCO2M MODEL 818 MONITOR2PMA Approval
- P800043RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO2PMA Approval
- 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
MODEL 515 NEONATAL MONIOTR
- Page Type
- PMA Approval
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- Applicant
- GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
- Trade Name
- MODEL 515 NEONATAL MONIOTR
- Generic Name
- MONITOR, CARBON-DIOXIDE, CUTANEOUS
- Decision Date
- 11/19/1986
- Days to Decision
- 153 days
- Decision Code
- APPR
- FDA Decision
- Approval