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

    DISPOS ACCESS EXTERNAL CARDIAC PACEMAKER

    K Number: K903437 · Decision Nov 16, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    83
    Applicant Total
    6
    Review Days
    108

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    Basic Information

    Device Name
    DISPOS ACCESS EXTERNAL CARDIAC PACEMAKER
    K Number
    K903437
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5550
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Keller Medical Specialties Products, Inc.
    Date Received
    July 31, 1990
    Decision Date
    November 16, 1990
    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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