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

    AVATRON UNIVERSAL ADULT VOL. VENTILATOR

    K Number: K842778 · Decision Jul 26, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    87
    Applicant Total
    5
    Review Days
    10

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    Basic Information

    Device Name
    AVATRON UNIVERSAL ADULT VOL. VENTILATOR
    K Number
    K842778
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5975
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Avatron, Inc.
    Date Received
    July 16, 1984
    Decision Date
    July 26, 1984
    Product Code
    BZO
    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
    BZO Set, Tubing And Support, Ventilator (W Harness)

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    Other Clearances by Avatron, Inc.

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