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

    MYOSYSTEM 1000 ELECTROMYOGRAPH

    K Number: K895635 · Decision Apr 19, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    171
    Applicant Total
    2
    Review Days
    212

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    Basic Information

    Device Name
    MYOSYSTEM 1000 ELECTROMYOGRAPH
    K Number
    K895635
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5050
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Noraxon USA, Inc.
    Date Received
    September 19, 1989
    Decision Date
    April 19, 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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    Other Clearances by Noraxon USA, Inc.

    K Number Device Name
    K895633 MYOTRACE 10 BIOFEEDBACK DEVICE