BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (CMS1700C)

    K Number: K232908 · Decision May 2, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    12
    Review Days
    226

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    Basic Information

    Device Name
    Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (CMS1700C)
    K Number
    K232908
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Contec Medical Systems Co.,Ltd
    Date Received
    September 19, 2023
    Decision Date
    May 2, 2024
    Product Code
    IYN
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IYN System, Imaging, Pulsed Doppler, Ultrasonic

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    Other Clearances by Contec Medical Systems Co.,Ltd

    K Number Device Name
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    K232895 B-Ultrasound Diagnostic System
    K220245 Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)
    K202757 CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor
    K201980 Infrared Thermometer
    K171360 CONTEC™ Electrocardiograph
    K170856 CMS600P2 B-Ultrasound Diagnostic System
    K170954 Portable ECG Monitor
    K152863 Portable ECG Monitor
    K141362 PULSE OXIMETER CMS50EW
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