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

    LIFE ISLAND 21

    K Number: K925651 · Decision Jul 27, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    101
    Applicant Total
    2
    Review Days
    260

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    Basic Information

    Device Name
    LIFE ISLAND 21
    K Number
    K925651
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5550
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Keisei (Usa) Co., Ltd.
    Date Received
    November 9, 1992
    Decision Date
    July 27, 1993
    Product Code
    FNM
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FNM Mattress, Air Flotation, Alternating Pressure

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    Other Clearances by Keisei (Usa) Co., Ltd.

    K Number Device Name
    K950613 KEISEI