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

    CARDIO MONITOR CENTER VISION; MODEL S-CV7-00

    K Number: K003392 · Decision Jan 25, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    574
    Applicant Total
    5
    Review Days
    86

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    Basic Information

    Device Name
    CARDIO MONITOR CENTER VISION; MODEL S-CV7-00
    K Number
    K003392
    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
    October 31, 2000
    Decision Date
    January 25, 2001
    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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