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FDA 510(k)

uMR 680

K-Number: K240744 · 2024-04-10

Decision Date2024-04-10
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

uMR 680 is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2024-04-10 under approval number K240744. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the uMR 680?

uMR 680 is a medical device that received FDA 510(k) clearance on 2024-04-10. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K240744.

When was uMR 680 approved by the FDA?

uMR 680 received FDA 510(k) clearance on 2024-04-10, under approval number K240744.

What company makes uMR 680?

uMR 680 is manufactured by Shanghai United Imaging Healthcare Co., Ltd..

What is the FDA product code for uMR 680?

The FDA product code for uMR 680 is LNH.

Other Devices by Shanghai United Imaging Healthcare Co., Ltd.

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Related Devices (Code: LNH)

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.