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

    PROTECT IV GARD

    K Number: K772060 · Decision Dec 20, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    374
    Registration Numbers
    374
    Same Product Code
    22
    Applicant Total
    10
    Review Days
    50

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    Basic Information

    Device Name
    PROTECT IV GARD
    K Number
    K772060
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6450
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Omnicon Medical Corp.
    Date Received
    October 31, 1977
    Decision Date
    December 20, 1977
    Product Code
    FMP
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FMP Protector, Skin Pressure

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    Other Clearances by Omnicon Medical Corp.

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    K801804 ANESTHESIA BACTERIA FILTER
    K801803 MAINFLOW BACTERIA FILTER
    K770136 DISPOSABLE BACTERIA FILTER
    K770001 AIRWAY, BERMAN 40, 60, 80, 90, L00MM'S
    K760819 CONDUCTIVE ANESTHESIA BREATHING CIRCUIT
    K760149 CONDUCTIVE ANESTHSIA BREATH. CIRCUIT