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

    MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084

    K Number: K101703 · Decision Jul 13, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    397
    Applicant Total
    49
    Review Days
    26

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    Basic Information

    Device Name
    MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084
    K Number
    K101703
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Card Guard Scientific Survival , Ltd.
    Date Received
    June 17, 2010
    Decision Date
    July 13, 2010
    Product Code
    DSI
    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
    DSI Detector And Alarm, Arrhythmia

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    K083174 HEALTHEPOD
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    K081257 CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR
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    K061428 PMP4 APPLICATION
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