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

    IMPULS 3, IT SELECTOR

    K Number: K842805 · Decision Aug 1, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    4
    Applicant Total
    21
    Review Days
    15

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    Basic Information

    Device Name
    IMPULS 3, IT SELECTOR
    K Number
    K842805
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.1850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Robert Bosch Corp.
    Date Received
    July 17, 1984
    Decision Date
    August 1, 1984
    Product Code
    ISB
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ISB Stimulator, Muscle, Diagnostic

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