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510(k) Data Aggregation

    K Number
    K142769
    Device Name
    Fetal Doppler
    Manufacturer
    iCare Newlife Technologies, Inc.
    Date Cleared
    2015-03-20

    (176 days)

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

    iCare Newlife Technologies, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The iCareNewlife Fetal Doppler is indicated for monitoring fetal heart rate during the antepartum period as a general indication of fetal well-being. The device is for heart sounds through the speaker only. The device is intended to be used by health care professionals including registered nurses, midwives, ultrasound technicians, and physician assistants, by prescription from licensed physicians in hospitals, clinics and private offices.
    Device Description
    The device is a hand-held ultrasonic fetal heart beat detector, which can detect the Fetal Heart Rate (FHR). The built-in speaker of the device allows for listening of the fetal heartbeat. The device is generally applied to above 16 weeks gestation. Ultrasonic wave is transmitted from one piezoelectric ceramic at the front of the uterus of the pregnant women. Echo is received by the other piezoelectric ceramic at the front of the probe when ultrasonic wave reaches the fetal heart. Then it is converted into voltage. This Doppler signal is detected and demodulated from the received signal. And the Doppler frequency is consistent with the rhythm of the fetal systole and diastole. Once cardiac valves vibrate and a Doppler frequency excursion is formed. lt is transmitted an output signal of cardiac valves vibrating, and it is sent to the loudspeaker for getting a rhythmical sound with the fetal heartbeat. The device is powered by a 9V alkaline battery.
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