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

    R2 PACE PAD, MODEL 480

    K Number: K895729 · Decision Oct 12, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    83
    Applicant Total
    2
    Review Days
    17

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    Basic Information

    Device Name
    R2 PACE PAD, MODEL 480
    K Number
    K895729
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5550
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Darox Corp.
    Date Received
    September 25, 1989
    Decision Date
    October 12, 1989
    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 Darox Corp.

    K Number Device Name
    K895728 R2 PACE ADAPTOR CABLE, MODEL 196