BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PENOX HIGH FLOW MANIFOLD

    K Number: K853775 · Decision Nov 29, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    54
    Applicant Total
    10
    Review Days
    80

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    Basic Information

    Device Name
    PENOX HIGH FLOW MANIFOLD
    K Number
    K853775
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5655
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Penox Technologies, Inc.
    Date Received
    September 10, 1985
    Decision Date
    November 29, 1985
    Product Code
    BYJ
    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
    BYJ Unit, Liquid-Oxygen, Portable

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    Other Clearances by Penox Technologies, Inc.

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    K851217 PENOX DUAL FLOW MINIFOLD
    K851216 PENOX DUAL FEED MANIFOLD
    K851215 T-HANDLE ADAPTER, U-HANDLE & L HANDLER ADAPTER
    K851219 FILL HOSE SAFETY ADAPTER