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

    CARDIOVISION SOFTWARE, MODEL S-CV5-96

    K Number: K981807 · Decision Aug 19, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    574
    Applicant Total
    5
    Review Days
    90

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    Basic Information

    Device Name
    CARDIOVISION SOFTWARE, MODEL S-CV5-96
    K Number
    K981807
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shl Telemedicine International , Ltd.
    Date Received
    May 21, 1998
    Decision Date
    August 19, 1998
    Product Code
    DPS
    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
    DPS Electrocardiograph

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    Other Clearances by Shl Telemedicine International , Ltd.

    K Number Device Name
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    K080047 CARDIOSEN'C
    K063609 RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER
    K003392 CARDIO MONITOR CENTER VISION; MODEL S-CV7-00