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

    CARDIOSEN'C

    K Number: K080047 · Decision Jul 11, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    80
    Registration Numbers
    80
    Same Product Code
    296
    Applicant Total
    5
    Review Days
    185

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    CARDIOSEN'C
    K Number
    K080047
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2920
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shl Telemedicine International , Ltd.
    Date Received
    January 8, 2008
    Decision Date
    July 11, 2008
    Product Code
    DXH
    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
    DXH Transmitters And Receivers, Electrocardiograph, Telephone

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DXH), ordered by most recent decision date.

    PreemptiveAI Clinical SDK

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HeartBeam AIMIGo with 12-L ECG Synthesis Software System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEMO Patch M (MPT-E08R-UNC01)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Hexoskin Medical System (7100-00016)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VitalSigns 1-Lead Holter (VSH101)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    QT ECG (QTERD100)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Shl Telemedicine International , Ltd.

    K Number Device Name
    K113514 SMARTHEART
    K063609 RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER
    K003392 CARDIO MONITOR CENTER VISION; MODEL S-CV7-00
    K981807 CARDIOVISION SOFTWARE, MODEL S-CV5-96