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

    FALL-SAFE MONITOR

    K Number: K841671 · Decision Jul 3, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    30
    Applicant Total
    2
    Review Days
    71

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    Basic Information

    Device Name
    FALL-SAFE MONITOR
    K Number
    K841671
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.2400
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Fsm Corp.
    Date Received
    April 23, 1984
    Decision Date
    July 3, 1984
    Product Code
    KMI
    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
    KMI Monitor, Bed Patient

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    Other Clearances by Fsm Corp.

    K Number Device Name
    K841672 FALL-SAFE VEST