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FDA 510(k)

Pocket Ultrasound System

K-Number: K211746 · 2022-02-18

ApplicantGuangdong Youkey Medical Co., Ltd.
Decision Date2022-02-18
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Pocket Ultrasound System is a medical device manufactured by Guangdong Youkey Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-02-18 under approval number K211746. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pocket Ultrasound System?

Pocket Ultrasound System is a medical device that received FDA 510(k) clearance on 2022-02-18. It is manufactured by Guangdong Youkey Medical Co., Ltd.. The 510(k) number is K211746.

When was Pocket Ultrasound System approved by the FDA?

Pocket Ultrasound System received FDA 510(k) clearance on 2022-02-18, under approval number K211746.

What company makes Pocket Ultrasound System?

Pocket Ultrasound System is manufactured by Guangdong Youkey Medical Co., Ltd..

What is the FDA product code for Pocket Ultrasound System?

The FDA product code for Pocket Ultrasound System is IYN.

Related Clinical Trials

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Other Devices by Guangdong Youkey Medical Co., Ltd.

K231930Digital Ultrasonic Diagnostic Imaging System (Model: F6)

Related Devices (Code: IYN)

K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi , Ltd. K163138Clarius Ultrasound SystemClarius Mobile Health Corp. K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics K162583ALOKA LISENDO 880Hitachi , Ltd. K163020Xperius Ultrasound SystemPhilips Health Care

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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