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
- K131881OMBRA TABLE TOP COMPRESSOR2Cleared 510(K)
- K113338MEDICAL AIR COMPRESSOR2Cleared 510(K)
- K091871DK50 DS2Cleared 510(K)
- K072634EMG TRITON -COMP,MODEL NCA01-XXX SERIES2Cleared 510(K)
- K060781MEDICAL COMPRESSOR, MODELS DK50 D AND DM2Cleared 510(K)
- K051691MINIMATE COMPRESSOR2Cleared 510(K)
- K041781VENTILAIR II MEDICAL AIR COMPRESSOR2Cleared 510(K)
- K041406NEWPORT C250 AIR COMPRESSOR MODEL C2502Cleared 510(K)
- K041974MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZER2Cleared 510(K)
- K040220MEDICAL AIR COMPRESSOR2Cleared 510(K)
Show All 74 Submissions
- BXJClip, Nose1Product Code
- BXKGas, Calibration (Specified Concentration)1Product Code
- 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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OMBRA TABLE TOP COMPRESSOR
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K131881
- 510(k) Type
- Traditional
- Applicant
- TRUDELL MEDICAL INTL.
- Country
- Canada
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/24/2013
- Days to Decision
- 121 days
- Submission Type
- Summary