uMR 580, uMR 588
K-Number: K183137 · 2019-01-11
Decision Date2019-01-11
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
uMR 580, uMR 588 is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2019-01-11 under approval number K183137. 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 580, uMR 588?
uMR 580, uMR 588 is a medical device that received FDA 510(k) clearance on 2019-01-11. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K183137.
When was uMR 580, uMR 588 approved by the FDA?
uMR 580, uMR 588 received FDA 510(k) clearance on 2019-01-11, under approval number K183137.
What company makes uMR 580, uMR 588?
uMR 580, uMR 588 is manufactured by Shanghai United Imaging Healthcare Co., Ltd..
What is the FDA product code for uMR 580, uMR 588?
The FDA product code for uMR 580, uMR 588 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.