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

    RESUSCITATOR VALVE ASSEMBLY W/FILTER

    K Number: K882204 · Decision Jul 8, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    102
    Applicant Total
    10
    Review Days
    44

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    Basic Information

    Device Name
    RESUSCITATOR VALVE ASSEMBLY W/FILTER
    K Number
    K882204
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5870
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Intertech/Ohio
    Date Received
    May 25, 1988
    Decision Date
    July 8, 1988
    Product Code
    CBP
    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
    CBP Valve, Non-Rebreathing

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