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

    MONITOR, ELECTROGRAPHIC

    K Number: K874319 · Decision Mar 7, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    338
    Applicant Total
    10
    Review Days
    138

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    Basic Information

    Device Name
    MONITOR, ELECTROGRAPHIC
    K Number
    K874319
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Medac, Inc.
    Date Received
    October 21, 1987
    Decision Date
    March 7, 1988
    Product Code
    DRT
    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
    DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

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    Other Clearances by Medac, Inc.

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    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
    K864987 DISPOS GEL EXTERNAL PACING ELECTRODE/HI IMPEDANCE