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FDA 510(k)

Ultrasonic Doppler (Model YM-2T8)

K-Number: K180419 · 2018-07-19

ApplicantShenzhen Imdk Medical Technology Co., Ltd.
Decision Date2018-07-19
Product CodeKNG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Ultrasonic Doppler (Model YM-2T8) is a medical device manufactured by Shenzhen Imdk Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-07-19 under approval number K180419. 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 Ultrasonic Doppler (Model YM-2T8)?

Ultrasonic Doppler (Model YM-2T8) is a medical device that received FDA 510(k) clearance on 2018-07-19. It is manufactured by Shenzhen Imdk Medical Technology Co., Ltd.. The 510(k) number is K180419.

When was Ultrasonic Doppler (Model YM-2T8) approved by the FDA?

Ultrasonic Doppler (Model YM-2T8) received FDA 510(k) clearance on 2018-07-19, under approval number K180419.

What company makes Ultrasonic Doppler (Model YM-2T8)?

Ultrasonic Doppler (Model YM-2T8) is manufactured by Shenzhen Imdk Medical Technology Co., Ltd..

What is the FDA product code for Ultrasonic Doppler (Model YM-2T8)?

The FDA product code for Ultrasonic Doppler (Model YM-2T8) is KNG.

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Other Devices by Shenzhen Imdk Medical Technology Co., Ltd.

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Related Devices (Code: KNG)

K153475SD5 & SD6 Ultrasonic Tabletop DopplerEdan Instruments, Inc. K182190Fetal DopplerShenzhen AOJ 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 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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