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

    DISPOS GEL EXTERNAL PACING ELECTRODE/HI IMPEDANCE

    K Number: K864987 · Decision Mar 3, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    83
    Applicant Total
    10
    Review Days
    71

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    Basic Information

    Device Name
    DISPOS GEL EXTERNAL PACING ELECTRODE/HI IMPEDANCE
    K Number
    K864987
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5550
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Medac, Inc.
    Date Received
    December 22, 1986
    Decision Date
    March 3, 1987
    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 Medac, Inc.

    K Number Device Name
    K874319 MONITOR, ELECTROGRAPHIC
    K874447 DISPOSABLE GEL DEFIBRILLATION/EXTERNAL PACING ELEC
    K874090 300M ECG MONITRO/TRANSCUTANEOUS PACEMAKER
    K874091 360D DC DEFIBRILLATOR
    K871176 PACE 10 NON-INVASIVE EXTERNAL PACEMAKER
    K864985 DISPOS GEL EXTERNAL PACING ELECTRODE/LOW IMPEDANCE
    K864986 ETP 300 NON-INVASIVE EXTERNAL PACEMAKER
    K864988 ETP 180E NON-INVASIVE EXTERNAL PACEMAKER
    K864989 ETP 180A NON-INVASIVE EXTERNAL PACEMAKER