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

    MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE

    K Number: K970051 · Decision Jul 10, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    171
    Applicant Total
    15
    Review Days
    184

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    Basic Information

    Device Name
    MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE
    K Number
    K970051
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5050
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smith and Nephew Donjoy, Inc.
    Date Received
    January 7, 1997
    Decision Date
    July 10, 1997
    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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