uMR 780, uMR 790
K-Number: K191157 · 2019-05-29
Decision Date2019-05-29
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
uMR 780, uMR 790 is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2019-05-29 under approval number K191157. 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 780, uMR 790?
uMR 780, uMR 790 is a medical device that received FDA 510(k) clearance on 2019-05-29. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K191157.
When was uMR 780, uMR 790 approved by the FDA?
uMR 780, uMR 790 received FDA 510(k) clearance on 2019-05-29, under approval number K191157.
What company makes uMR 780, uMR 790?
uMR 780, uMR 790 is manufactured by Shanghai United Imaging Healthcare Co., Ltd..
What is the FDA product code for uMR 780, uMR 790?
The FDA product code for uMR 780, uMR 790 is LNH.
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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.