FDA 510(k)

Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)

Número K: K220245 · 2022-09-28

RequerenteContec Medical Systems Co.,Ltd

Data da decisão2022-09-28

Código do produtoKNG

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) is the device name listed in this FDA 510(k) record. The listed applicant is Contec Medical Systems Co.,Ltd. It received FDA 510(k) clearance on 2022-09-28 under 510(k) number K220245. 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 Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)?

Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) is a medical device that received FDA 510(k) clearance on 2022-09-28. The listed applicant is Contec Medical Systems Co.,Ltd. The 510(k) number is K220245.

When did Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) receive FDA 510(k) clearance?

Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) received FDA 510(k) clearance on 2022-09-28, under 510(k) number K220245.

Who is the listed applicant for Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)?

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

What is the FDA product code for Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)?

The FDA product code for Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) is KNG.

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Outros registros que listam Contec Medical Systems Co.,Ltd como candidato(a)

K232893Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)K232895B-Ultrasound Diagnostic System K232908Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (CMS1700C)K202757CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor K201980Infrared Thermometer K171360CONTEC™ Electrocardiograph

Ver todos os 10 dispositivos →

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 K211940Fetal DopplerShenzhen Taikang Medical Equipment Co., Ltd.K212084Fetal DopplerShenzhen Mericonn Technology Co., Ltd.

Fonte oficial

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