BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    PERSONAL ALERT ASSIST DEVICE

    K Number: K890445 · Decision May 19, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    7
    Applicant Total
    2
    Review Days
    112

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    Basic Information

    Device Name
    PERSONAL ALERT ASSIST DEVICE
    K Number
    K890445
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4820
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Silent Call Corp.
    Date Received
    January 27, 1989
    Decision Date
    May 19, 1989
    Product Code
    LXI
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LXI Guide, Drill, Ligament

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    Other Clearances by Silent Call Corp.

    K Number Device Name
    K890596 MED-A-CALL ASSIST DEVICE