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

    DOPPLER FETAL HEARTBEAT RATE DETECTOR

    K Number: K090510 · Decision Apr 29, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    59
    Applicant Total
    2
    Review Days
    427

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    Basic Information

    Device Name
    DOPPLER FETAL HEARTBEAT RATE DETECTOR
    K Number
    K090510
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2660
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Bestman Instrument Co., Ltd.
    Date Received
    February 26, 2009
    Decision Date
    April 29, 2010
    Product Code
    KNG
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    RA
    Third Party
    Y

    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 Shenzhen Bestman Instrument Co., Ltd.

    K Number Device Name
    K242846 Doppler FHR Detector (BF-500D+, BF-560)