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

    DYNATRON 350 EMG/BIOFEEDBACK ANALYZER

    K Number: K900639 · Decision Oct 4, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    113
    Same Product Code
    171
    Applicant Total
    5
    Review Days
    237

    Basic Information

    Device Name
    DYNATRON 350 EMG/BIOFEEDBACK ANALYZER
    K Number
    K900639
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5050
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    DYNATRONICS LASER CORP.
    Date Received
    February 9, 1990
    Decision Date
    October 4, 1990
    Product Code
    HCC
    Advisory Committee
    Neurology
    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
    HCC Device, Biofeedback

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