Anesthesiology
Review Panel
- Cardiovascular Diagnostic DevicesCFR Sub-Part
- Cardiovascular Monitoring DevicesCFR Sub-Part
- Cardiovascular Therapeutic DevicesCFR Sub-Part
- Diagnostic DevicesCFR Sub-Part
- MiscellaneousCFR Sub-Part
- BRXStool, Anesthesia1Product Code
- BRYCabinet, Table And Tray, Anesthesia1Product Code
- BSYCatheters, Suction, Tracheobronchial1Product Code
- BTICompressor, Air, Portable2Product Code
- BXJClip, Nose1Product Code
- BXKGas, Calibration (Specified Concentration)1Product Code
- K954803BLOOD GAS MIXTURES1Cleared 510(K)
- K954804LUNG DIFFUSION MIXTURES1Cleared 510(K)
- K954542LUNG DIFFUSION MIXTURE1Cleared 510(K)
- K952838MEDICAL MIXTURE-LUNG DIFFUSION GAS MIXTURES1Cleared 510(K)
- K953934MED-TECH LUNG DIFFUSION MIXTURE1Cleared 510(K)
- K953208MEDICAL MIXTURE-CLINICAL BLOOD GAS MIXTURES1Cleared 510(K)
- K944998CALIBRATION GAS1Cleared 510(K)
- K944812CLINICAL BLOOD GAS MIXTURE1Cleared 510(K)
- K942866CLINICAL BLOOD GAS MIXTURE1Cleared 510(K)
- K932874BLOOD GAS MIXTURE1Cleared 510(K)
- Show All 32 Submissions
- BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)1Product Code
- CAMYoke Assembly, Medical Gas1Product Code
- CCXSupport, Patient Position1Product Code
- OFOAirway Suction Kit1Product Code
- OFRTracheobronchial Suction Catheter Kit1Product Code
- OFSTracheal Suction Set1Product Code
- OYINon-Bronchoscopic Bronchoalveolar Lavage Catheter1Product Code
- BSDAnalyzer, Gas, Nitrogen, Partial Pressure, Blood-Phase, Non-Indwelling3Product Code
- LSZVentilator, High Frequency3Product Code
- LYMDevice, Cpr AssistUProduct Code
- MNQStimulator, Hypoglossal Nerve, Implanted, Apnea3Product Code
- NJKValve, Pulmonary3Product Code
- OAZOne-Way Air-Leak ValveFProduct Code
- OIRDiaphragmatic/Phrenic Nerve Laparoscopically-Implanted StimulatorFProduct Code
- OOYBronchial Thermoplasty System3Product Code
- PDRComputer-Assisted Personalized Sedation System3Product Code
- PNCCatheter IntroducerNProduct Code
- POILung Tissue Sealant For Lung Volume ReductionNProduct Code
- PSRImplanted Phrenic Nerve Stimulator For Central Sleep Apnea3Product Code
- QGZElectrical Tumor Treatment Fields3Product Code
- QKSInhaler, Metered Dose Or Dry Powder, Cder Or Cber LedNProduct Code
- QLIVaporizer, Cder Or Cber LedNProduct Code
- QOQNon-Continuous Ventilator For Emergency UseNProduct Code
- QORContinuous Ventilator, Minimal Ventilatory SupportNProduct Code
- QOUEmergency ResuscitatorNProduct Code
- QOWVentilatory Assistance HelmetNProduct Code
- QPRNeurological Stimulation For Emergency UseNProduct Code
- QRSDevice For Sleep Apnea Testing Based On Mandibular Movement2Product Code
- QSFSoftware Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents3Product Code
- Submissions with No Product CodeMiscellaneous
- Monitoring DevicesCFR Sub-Part
- Neurological Therapeutic DevicesCFR Sub-Part
- Physical Medicine Therapeutic DevicesCFR Sub-Part
- Prosthetic DevicesCFR Sub-Part
- Surgical DevicesCFR Sub-Part
- Therapeutic DevicesCFR Sub-Part
- CardiovascularReview Panel
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CALIBRATION GAS
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K944998
- 510(k) Type
- Traditional
- Applicant
- SUNOX, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/3/1995
- Days to Decision
- 113 days
- Submission Type
- Summary