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FDA 510(k)

Digital Ultrasonic Diagnostic Imaging System (Model: F6)

K-Number: K231930 · 2024-03-22

Decision Date2024-03-22
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Digital Ultrasonic Diagnostic Imaging System (Model: F6) 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 2024-03-22 under 510(k) number K231930. 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 Digital Ultrasonic Diagnostic Imaging System (Model: F6)?

Digital Ultrasonic Diagnostic Imaging System (Model: F6) is a medical device that received FDA 510(k) clearance on 2024-03-22. The listed applicant is Guangdong Youkey Medical Co., Ltd.. The 510(k) number is K231930.

When did Digital Ultrasonic Diagnostic Imaging System (Model: F6) receive FDA 510(k) clearance?

Digital Ultrasonic Diagnostic Imaging System (Model: F6) received FDA 510(k) clearance on 2024-03-22, under 510(k) number K231930.

Who is the listed applicant for Digital Ultrasonic Diagnostic Imaging System (Model: F6)?

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 Digital Ultrasonic Diagnostic Imaging System (Model: F6)?

The FDA product code for Digital Ultrasonic Diagnostic Imaging System (Model: F6) 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.

Related Devices (Code: IYN)

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.

Official Source

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