BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MEDI-DX 7000

    K Number: K964622 · Decision Dec 1, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    12
    Applicant Total
    2
    Review Days
    378

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    Basic Information

    Device Name
    MEDI-DX 7000
    K Number
    K964622
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    882.1200
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neuro-Diagnostic Assoc.
    Date Received
    November 18, 1996
    Decision Date
    December 1, 1997
    Product Code
    LLN
    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
    LLN Device, Vibration Threshold Measurement

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    Other Clearances by Neuro-Diagnostic Assoc.

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    K980866 MEDI-DX 7000 CPT WITH AMREX ELECTRODES