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

    TRUVUE WIRELESS AMBULATORY ECG MONITORING SYSTEM

    K Number: K100155 · Decision Apr 20, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    397
    Applicant Total
    2
    Review Days
    90

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    Basic Information

    Device Name
    TRUVUE WIRELESS AMBULATORY ECG MONITORING SYSTEM
    K Number
    K100155
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomedical Systems Corp.
    Date Received
    January 20, 2010
    Decision Date
    April 20, 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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    Other Clearances by Biomedical Systems Corp.

    K Number Device Name
    K024323 CENTURY SERIES HOLTER SCANNER SYSTEM, MODELS C3000, C2000 AND C1000