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
- 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
- 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
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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