Anesthesiology
Review Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Neurological 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
- K954804LUNG DIFFUSION MIXTURES1Cleared 510(K)
- K954803BLOOD GAS 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)
- K935311CLINICAL BLOOD GAS1Cleared 510(K)
- K932520CALIBRATION GAS1Cleared 510(K)
- K924795BLOOD GAS MIXTURE1Cleared 510(K)
- K924796LUNG DIFFUSION GAS MIXTURE1Cleared 510(K)
- K911264CALIBRATION KIT1Cleared 510(K)
- K911471LUNG DIFFUSION GAS MIXTURES1Cleared 510(K)
- K902754ANESTHETIC GAS CALIBRATION MIXTURE1Cleared 510(K)
- K882210MEDIBLEND (TM) LUNG DIFFUSION GAS MIXTURES1Cleared 510(K)
- K873586LUNG DIFFUSION GAS1Cleared 510(K)
- K874297CALIBRATION GAS FOR CARBON DIOXIDE MONITOR1Cleared 510(K)
- K873587BLOOD ANALYSIS GAS1Cleared 510(K)
- K871100O.1 TO 25.0% CARB. DIOX. U.S.P. BALANCE OXYGEN USP1Cleared 510(K)
- K871103O.1 T0 40.0% CARBON DIOX. O.1 TO 90.0% OXY. U.S.P1Cleared 510(K)
- K871102O.1 TO 50.0% CARBON DIOXIDE, USP BALANCE NITRO.,NF1Cleared 510(K)
- K8711010.1 TO 25.0% OXYGEN, USP, BALANCE NITROGEN, N.F.1Cleared 510(K)
- K870139GAS, CALIBRATION, SPECIFIED CONCENTRATION1Cleared 510(K)
- K863675CALIBRATION GAS FOR SERVO GAS MONITOR 1201Cleared 510(K)
- K822764LUNG DIFFUSION MIXTURE1Cleared 510(K)
- K822763CLINICAL GAS MIXTURE-NON-FLAMMABLE1Cleared 510(K)
- K822762CLINICAL GAS MIXTURE-FLAMMABLE1Cleared 510(K)
- K822753BLOOD GAS MIXTURE1Cleared 510(K)
- K822752ANAEROBIC CARBON DIOXIDE1Cleared 510(K)
- 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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- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
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- UnknownReview Panel
CALIBRATION KIT
- Page Type
- Cleared 510(K)
- 510(k) Number
- K911264
- 510(k) Type
- Traditional
- Applicant
- S & W MEDICO TEKNIK
- Country
- Denmark
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/2/1991
- Days to Decision
- 144 days