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

    VENTILATOR, MODEL AVA-1, ADULT

    K Number: K782074 · Decision Dec 21, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    504
    Applicant Total
    4
    Review Days
    8

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    Basic Information

    Device Name
    VENTILATOR, MODEL AVA-1, ADULT
    K Number
    K782074
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Rule Medical Instruments, Inc.
    Date Received
    December 13, 1978
    Decision Date
    December 21, 1978
    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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    Other Clearances by Rule Medical Instruments, Inc.

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