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

    PACEMAKER PULSE GENERATOR W/ELECTRODE

    K Number: K840353 · Decision Apr 23, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    83
    Applicant Total
    2
    Review Days
    88

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    Basic Information

    Device Name
    PACEMAKER PULSE GENERATOR W/ELECTRODE
    K Number
    K840353
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5550
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Ross Research, Inc.
    Date Received
    January 26, 1984
    Decision Date
    April 23, 1984
    Product Code
    DRO
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)

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    Other Clearances by Ross Research, Inc.

    K Number Device Name
    K822246 NONINVASIVE TEMPORARY PACEMAKER