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
- BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)1Product Code
- CAMYoke Assembly, Medical Gas1Product Code
- K935283YOKE ASSEMBLY MEDICAL GAS1Cleared 510(K)
- K851217PENOX DUAL FLOW MINIFOLD1Cleared 510(K)
- K851215T-HANDLE ADAPTER, U-HANDLE & L HANDLER ADAPTER1Cleared 510(K)
- K851216PENOX DUAL FEED MANIFOLD1Cleared 510(K)
- K851219FILL HOSE SAFETY ADAPTER1Cleared 510(K)
- K840326GAS SUPPLY MANIFOLD SIEMENS-ELEMA AB1Cleared 510(K)
- K780365OXYGEN/NITROUS OXIDE OUTLET1Cleared 510(K)
- K770426OXYGEN MANIFOLD SYSTEMS, NITROUS OXIDE1Cleared 510(K)
- 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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T-HANDLE ADAPTER, U-HANDLE & L HANDLER ADAPTER
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K851215
- 510(k) Type
- Traditional
- Applicant
- PENOX TECHNOLOGIES, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/18/1985
- Days to Decision
- 84 days