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

    J4 MYO-MONITOR

    K Number: K842223 · Decision Nov 19, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    8
    Applicant Total
    8
    Review Days
    167

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    Basic Information

    Device Name
    J4 MYO-MONITOR
    K Number
    K842223
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Myo-Tronics Research, Inc.
    Date Received
    June 5, 1984
    Decision Date
    November 19, 1984
    Product Code
    NUW
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NUW Stimulator, Muscle, Powered, Dental

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    Other Clearances by Myo-Tronics Research, Inc.

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