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

    IPPB ASSEMBLY W/NEBULIZER

    K Number: K781232 · Decision Sep 27, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    24
    Applicant Total
    2
    Review Days
    68

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    Basic Information

    Device Name
    IPPB ASSEMBLY W/NEBULIZER
    K Number
    K781232
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5905
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Rtec
    Date Received
    July 21, 1978
    Decision Date
    September 27, 1978
    Product Code
    NHJ
    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
    NHJ Device, Positive Pressure Breathing, Intermittent

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    Other Clearances by Rtec

    K Number Device Name
    K781231 OXYGEN SUPPLY TUBE, DISP., PLASTIC