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

    VENTILATOR TEST LUNG

    K Number: K800125 · Decision Jan 24, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    498
    Applicant Total
    12
    Review Days
    6

    Basic Information

    Device Name
    VENTILATOR TEST LUNG
    K Number
    K800125
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    BIO-MED DEVICES, INC.
    Date Received
    January 18, 1980
    Decision Date
    January 24, 1980
    Product Code
    CBK
    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
    CBK Ventilator, Continuous, Facility Use

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