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

    SD PLUS CLINICIAN CAT# 78-8015

    K Number: K840964 · Decision Apr 23, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    184
    Registration Numbers
    184
    Same Product Code
    605
    Applicant Total
    152
    Review Days
    48

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    Basic Information

    Device Name
    SD PLUS CLINICIAN CAT# 78-8015
    K Number
    K840964
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Codman & Shurtleff, Inc.
    Date Received
    March 6, 1984
    Decision Date
    April 23, 1984
    Product Code
    GZJ
    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
    GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

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