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

    LIFEMASK FACE SHIELD

    K Number: K953824 · Decision Sep 19, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    208
    Applicant Total
    2
    Review Days
    35

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    Basic Information

    Device Name
    LIFEMASK FACE SHIELD
    K Number
    K953824
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5915
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Carefree Trading, Inc.
    Date Received
    August 15, 1995
    Decision Date
    September 19, 1995
    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 Carefree Trading, Inc.

    K Number Device Name
    K954426 CPR LIFE MASK COMPACT BARRIER