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

    MOUTH-TO-MASK VENTILATORY ADJUNCT

    K Number: K883766 · Decision Oct 21, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    12
    Applicant Total
    1
    Review Days
    45

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    Basic Information

    Device Name
    MOUTH-TO-MASK VENTILATORY ADJUNCT
    K Number
    K883766
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5570
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Medic One
    Date Received
    September 6, 1988
    Decision Date
    October 21, 1988
    Product Code
    KGB
    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
    KGB Mask, Oxygen, Non-Rebreathing

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