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FDA 510(k)

Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D)

K-Number: K182526 · 2019-05-29

ApplicantVcomin Technology Limited
Decision Date2019-05-29
Product CodeKNG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D) is a medical device manufactured by Vcomin Technology Limited. It received FDA 510(k) clearance on 2019-05-29 under approval number K182526. 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 Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D)?

Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D) is a medical device that received FDA 510(k) clearance on 2019-05-29. It is manufactured by Vcomin Technology Limited. The 510(k) number is K182526.

When was Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D) approved by the FDA?

Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D) received FDA 510(k) clearance on 2019-05-29, under approval number K182526.

What company makes Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D)?

Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D) is manufactured by Vcomin Technology Limited.

What is the FDA product code for Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D)?

The FDA product code for Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D) 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

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. K182710Fetal Doppler, Model FD88Shenzzhen Luckcome Technology Inc., 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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