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

    EMG-1, MOTOR NERVE MONITOR

    K Number: K864408 · Decision Jan 30, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    74
    Applicant Total
    2
    Review Days
    81

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    EMG-1, MOTOR NERVE MONITOR
    K Number
    K864408
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.1375
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Algotek, Inc.
    Date Received
    November 10, 1986
    Decision Date
    January 30, 1987
    Product Code
    IKN
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IKN Electromyograph, Diagnostic

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (IKN), ordered by most recent decision date.

    Natus VikingQuest

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ViMove2

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Cadwell Sierra Summit, Cadwell Sierra Ascent

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ViMove

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    VIMOVE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine
    View all

    Other Clearances by Algotek, Inc.

    K Number Device Name
    K852687 ALGO I