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

    TENS MAX

    K Number: K823388 · Decision Jan 8, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    54

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    Basic Information

    Device Name
    TENS MAX
    K Number
    K823388
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7340
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Fujisawa Electronics Co.
    Date Received
    November 15, 1982
    Decision Date
    January 8, 1983
    Product Code
    GFK
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GFK Fibrinogen Determination Standards And Controls