BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    US SENSOR #CG-930P; TOCO SENSOR CG-940P

    K Number: K003876 · Decision Jul 9, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    6
    Applicant Total
    49
    Review Days
    206

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    Basic Information

    Device Name
    US SENSOR #CG-930P; TOCO SENSOR CG-940P
    K Number
    K003876
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2660
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Card Guard Scientific Survival , Ltd.
    Date Received
    December 15, 2000
    Decision Date
    July 9, 2001
    Product Code
    HEL
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HEL Monitor, Heart Rate, Fetal, Ultrasonic

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    MINIVISOR

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
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    Other Clearances by Card Guard Scientific Survival , Ltd.

    K Number Device Name
    K111745 KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER
    K110499 CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR
    K101703 MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084
    K101639 CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTOR
    K083174 HEALTHEPOD
    K082521 EASY2CHECK BLOOD GLUCOSE AND BLOOD PRESSURE MONITORING SYSTEM
    K081257 CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR
    K071995 CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR
    K061428 PMP4 APPLICATION
    K061528 SELFCHECK GLUCO
    Search all 49 clearances from Card Guard Scientific Survival , Ltd. →