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

    RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM

    K Number: K963120 · Decision Feb 28, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    83
    Applicant Total
    82
    Review Days
    200

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    Basic Information

    Device Name
    RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM
    K Number
    K963120
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5550
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Marquette Electronics, Inc.
    Date Received
    August 12, 1996
    Decision Date
    February 28, 1997
    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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    K962827 ALARM DISPLAY UNIT/PAGER-LAN SYSTEM (ADU)
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