FDA 510(k)

Fetal Doppler

Número K: K211940 · 2022-01-07

RequerenteShenzhen Taikang Medical Equipment Co., Ltd.

Data da decisão2022-01-07

Código do produtoKNG

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Fetal Doppler is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Taikang Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2022-01-07 under 510(k) number K211940. The device is classified under product code KNG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Fetal Doppler?

Fetal Doppler is a medical device that received FDA 510(k) clearance on 2022-01-07. The listed applicant is Shenzhen Taikang Medical Equipment Co., Ltd.. The 510(k) number is K211940.

When did Fetal Doppler receive FDA 510(k) clearance?

Fetal Doppler received FDA 510(k) clearance on 2022-01-07, under 510(k) number K211940.

Who is the listed applicant for Fetal Doppler?

The FDA 510(k) record lists Shenzhen Taikang Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fetal Doppler?

The FDA product code for Fetal Doppler is KNG.

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Dispositivos Relacionados (Código: KNG)

K252669Fetal Doppler U8-25, U9-25Zhongshan Xiaolan Town Senlan Electronic Factory K242846Doppler FHR Detector (BF-500D+, BF-560)Shenzhen Bestman Instrument Co., Ltd.K233823Ultrasonic Fetal DopplerShenzhen Jamr Technology Co., Ltd.K232893Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)Contec Medical Systems Co.,Ltd K220245Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)Contec Medical Systems Co.,Ltd K212084Fetal DopplerShenzhen Mericonn Technology Co., Ltd.

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