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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 a medical device manufactured by Contec Medical Systems Co.,Ltd. It received FDA 510(k) clearance on 2022-09-28 under approval 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. It is manufactured by Contec Medical Systems Co.,Ltd. The 510(k) number is K220245.

When was Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) approved by the FDA?

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

What company makes Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)?

Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) is manufactured by Contec Medical Systems Co.,Ltd.

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.

Related Clinical Trials

NCT06861309 Placental Imaging Techniques RECRUITING NCT01400880 Electrode-based Sensor for Non-invasive Fetal Heart Rate and EMG Monitoring With Improved Reliability COMPLETED

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Related Devices (Code: KNG)

K153475SD5 & SD6 Ultrasonic Tabletop DopplerEdan Instruments, Inc. K182190Fetal DopplerShenzhen AOJ Medical Technology Co., Ltd. K180419Ultrasonic Doppler (Model YM-2T8)Shenzhen Imdk Medical Technology Co., Ltd. K172780SD1 Ultrasonic Pocket DopplerEdan Instruments, Inc. K191110HeraBEAT™ USHeramed, Ltd. K182526Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D)Vcomin Technology Limited

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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