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    K Number
    K252669

    Validate with FDA (Live)

    Device Name
    Fetal Doppler U8-25, U9-25
    Manufacturer
    Zhongshan Xiaolan Town Senlan Electronic Factory
    Date Cleared
    2026-01-08

    (136 days)

    Product Code
    KNG
    Regulation Number
    884.2660
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Age Range
    0.31 - 120
    Reference & Predicate Devices
    K211940
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Fetal Doppler is used to detect the fetal heart rate. The device should be used by health care professionals including nurses, midwives, and specialized technicians in hospital, clinic, community and home. The device is intended for use at or after 16 weeks gestation.

    Device Description

    The Fetal Doppler U8-25, U9-25 is a handheld ultrasound device that employs the Doppler principle to detect the fetal heart rate (FHR) from a pregnant woman's abdomen.

    The fetal doppler has a main unit and a probe. The main unit consists of main board, power module, battery, speaker and display screen. The probe integrated into the main unit consists of the ultrasonic transducers for signal transmission and reception. The ultrasonic signal is continuously transmitted at a frequency of 2.5 MHz.

    The difference between U8-25 and U9-25 is their appearance. Except their appearances, there are no other differences between the fetal dopplers. They have the same intended use, power supply, and discharge holes close to a speaker.

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