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

    RESUS-AID DISPOSABLE RESUSCITATION SHIELD

    K Number: K852096 · Decision Jul 8, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    208
    Applicant Total
    2
    Review Days
    55

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    Basic Information

    Device Name
    RESUS-AID DISPOSABLE RESUSCITATION SHIELD
    K Number
    K852096
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5915
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Emergency Situation Products
    Date Received
    May 14, 1985
    Decision Date
    July 8, 1985
    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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    Other Clearances by Emergency Situation Products

    K Number Device Name
    K852095 ESP EMERGENCY CARE KIT