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

    VENTILATOR EXTERNAL BODY NEGATIVE PRESS

    K Number: K841090 · Decision May 30, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    20
    Applicant Total
    1
    Review Days
    78

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    Basic Information

    Device Name
    VENTILATOR EXTERNAL BODY NEGATIVE PRESS
    K Number
    K841090
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5935
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Porta-Lung Co.
    Date Received
    March 13, 1984
    Decision Date
    May 30, 1984
    Product Code
    BYT
    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
    BYT Ventilator, External Body, Negative Pressure, Adult (Cuirass)

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