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 the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Youkey Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-02-18 under 510(k) 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. The listed applicant is Guangdong Youkey Medical Co., Ltd.. The 510(k) number is K211746.

When did Pocket Ultrasound System receive FDA 510(k) clearance?

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

Who is the listed applicant for Pocket Ultrasound System?

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

What is the FDA product code for Pocket Ultrasound System?

The FDA product code for Pocket Ultrasound System is IYN.

Other records listing Guangdong Youkey Medical Co., Ltd. as applicant

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.