BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    YOKE ASSEMBLY MEDICAL GAS

    K Number: K935283 · Decision Mar 11, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    128

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    YOKE ASSEMBLY MEDICAL GAS
    K Number
    K935283
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.6885
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    American Gage & Medical, Inc.
    Date Received
    November 3, 1993
    Decision Date
    March 11, 1994
    Product Code
    CAM
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CAM Yoke Assembly, Medical Gas

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (CAM), ordered by most recent decision date.

    PENOX DUAL FLOW MINIFOLD

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    PENOX DUAL FEED MANIFOLD

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    T-HANDLE ADAPTER, U-HANDLE & L HANDLER ADAPTER

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    FILL HOSE SAFETY ADAPTER

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    GAS SUPPLY MANIFOLD SIEMENS-ELEMA AB

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    OXYGEN/NITROUS OXIDE OUTLET

    FDA 510(k)
    FDA Class 1 ·Anesthesiology
    View all