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

    Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)

    K Number: K220245 · Decision Sep 28, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    59
    Applicant Total
    12
    Review Days
    243

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    Basic Information

    Device Name
    Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)
    K Number
    K220245
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2660
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Contec Medical Systems Co.,Ltd
    Date Received
    January 28, 2022
    Decision Date
    September 28, 2022
    Product Code
    KNG
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KNG Monitor, Ultrasonic, Fetal

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    Other Clearances by Contec Medical Systems Co.,Ltd

    K Number Device Name
    K232893 Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)
    K232895 B-Ultrasound Diagnostic System
    K232908 Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (CMS1700C)
    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
    Search all 12 clearances from Contec Medical Systems Co.,Ltd →