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510(k) Data Aggregation

    K Number
    K242846
    Device Name
    Doppler FHR Detector (BF-500D+, BF-560)
    Manufacturer
    Shenzhen Bestman Instrument Co., Ltd.
    Date Cleared
    2025-06-26

    (279 days)

    Product Code
    KNG
    Regulation Number
    884.2660
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen Bestman Instrument Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Doppler FHR Detector (Model BF-500D+ and BF-560) is intended to detect fetal heart beats, display fetal heart rate, and play the fetal heart sound in patients with singleton pregnancies after 12 weeks of gestation. The device is intended to be used by health care professionals in a hospital, clinic, community, and home setting.
    Device Description
    The Fetal Doppler is a hand-held device for non-invasive measurement and display of the fetal heart beat utilizing Doppler ultrasound. The device consists of two main components, the main unit and probe. The main unit consists of the main board, power module, battery, speaker, and liquid crystal display(LCD) screen. The wired probe consists of the transducer and includes two angled semi-circle ultrasonic crystals, one for transmission and one for reception. The ultrasonic signal is continuously transmitted at one frequency. The difference between BF-500D+ and BF-560 are shown as below: - BF-500D+ is powered by a 9V rechargeable Ni-MH battery, and adapter is packaged with the unit; BF-560 is powered by three pieces of 1.5V AA alkaline disposable batteries. - BF-500D+ will display Fetal heart rate, sound volume, and battery indicator; BF-560 will also display the selected working frequency besides in addition to the features of the BF-500D+. - the two models have different probe shapes.
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    K Number
    K090510
    Device Name
    DOPPLER FETAL HEARTBEAT RATE DETECTOR
    Manufacturer
    SHENZHEN BESTMAN INSTRUMENT CO., LTD.
    Date Cleared
    2010-04-29

    (427 days)

    Product Code
    KNG
    Regulation Number
    884.2660
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHENZHEN BESTMAN INSTRUMENT CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This Doppler can be used for the detection of average fetal heartbeat rate.
    Device Description
    Doppler fetal heartbeat rate detector uses Doppler principle of ultrasound signal to detect the fetal heart rate. Doppler fetal heartbeat rate detector uses a split D piezoelectric transducer. A high frequency oscillator supplies a continuous high frequency voltage to one half of the split D transmitter transducer. The high frequency voltage is converted to an ultrasound acoustic wave by the transducer and is transmitted to biophysical objects through an applied coupling water based medium and moves through biophysical objects. The acoustic ultrasound is reflected by body and moving objects such as the fetal heart. The reflected ultrasound is received by the second split D receiver transducer and is converted via the piezoelectric effect into a high frequency electronic signal. The received electronic signal is amplified and detected. The result is a base band audio Doppler shifted signal which is filtered and converted to audio via a loudspeaker. At the same time the fetal heart rate is displayed on a liquid crystal arithmometer display.
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