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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 the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Imdk Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-07-19 under 510(k) 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. The listed applicant is Shenzhen Imdk Medical Technology Co., Ltd.. The 510(k) number is K180419.

When did Ultrasonic Doppler (Model YM-2T8) receive FDA 510(k) clearance?

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

Who is the listed applicant for Ultrasonic Doppler (Model YM-2T8)?

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

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

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

Other records listing Shenzhen Imdk Medical Technology Co., Ltd. as applicant

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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.,LtdK220245Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)Contec Medical Systems Co.,LtdK211940Fetal DopplerShenzhen Taikang Medical Equipment 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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