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

    NEGATIVE PRESSURE CHEST RESPIRATOR PUMP

    K Number: K832176 · Decision Sep 12, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    20
    Applicant Total
    25
    Review Days
    68

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    Basic Information

    Device Name
    NEGATIVE PRESSURE CHEST RESPIRATOR PUMP
    K Number
    K832176
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5935
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    J. H. Emerson Co.
    Date Received
    July 6, 1983
    Decision Date
    September 12, 1983
    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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