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FDA 510(k)

Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)

K-Number: K220245 · 2022-09-28

ApplicantContec Medical Systems Co.,Ltd
Decision Date2022-09-28
Product CodeKNG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Contec Medical Systems Co.,Ltd as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232893Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)K232895B-Ultrasound Diagnostic SystemK232908Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (CMS1700C)K202757CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure MonitorK201980Infrared ThermometerK171360CONTEC™ Electrocardiograph

View all 10 devices →

Related Devices (Code: KNG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252669Fetal Doppler U8-25, U9-25Zhongshan Xiaolan Town Senlan Electronic FactoryK242846Doppler 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.,LtdK211940Fetal DopplerShenzhen Taikang Medical Equipment Co., Ltd.K212084Fetal DopplerShenzhen Mericonn Technology Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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