uPMR 790
K-Number: K183014 · 2019-02-27
Decision Date2019-02-27
Product CodeOUO
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
uPMR 790 is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2019-02-27 under approval number K183014. The device is classified under product code OUO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the uPMR 790?
uPMR 790 is a medical device that received FDA 510(k) clearance on 2019-02-27. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K183014.
When was uPMR 790 approved by the FDA?
uPMR 790 received FDA 510(k) clearance on 2019-02-27, under approval number K183014.
What company makes uPMR 790?
uPMR 790 is manufactured by Shanghai United Imaging Healthcare Co., Ltd..
What is the FDA product code for uPMR 790?
The FDA product code for uPMR 790 is OUO.
Other Devices by Shanghai United Imaging Healthcare Co., Ltd.
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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.