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

    FLYNN SERIES III BAG/MASK UNIT-

    K Number: K832495 · Decision Sep 29, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    208
    Applicant Total
    14
    Review Days
    64

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    Basic Information

    Device Name
    FLYNN SERIES III BAG/MASK UNIT-
    K Number
    K832495
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5915
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    O-Two Systems Intl., Inc.
    Date Received
    July 27, 1983
    Decision Date
    September 29, 1983
    Product Code
    BTM
    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
    BTM Ventilator, Emergency, Manual (Resuscitator)

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