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510(k) Data Aggregation
K Number
K211940Device Name
Fetal Doppler
Manufacturer
Shenzhen Taikang Medical Equipment Co., Ltd.
Date Cleared
2022-01-07
(198 days)
Product Code
KNG
Regulation Number
884.2660Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Taikang Medical Equipment Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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, model TK-T802CR, is a hand-held, battery powered audio Doppler device used for detecting fetal heart beats and sounds. The Fetal Doppler is used for non-invasive detection and display of the fetal heart rate (FHR) utilizing Doppler ultrasound. It has two hand-held components, a main unit and a probe. The main unit consists of the main board, power module, battery, speaker, and LCD screen. The probe consists of the ultrasonic transducers for transmission and for signal reception. The ultrasonic signal is continuously transmitted at a frequency of 2.0, 2.5, or 3.0 MHz, depending on the probe settings selected.
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