K-number	K183014
Device name	uPMR 790
Applicant	Shanghai United Imaging Healthcare Co., Ltd.
Product code	OUO
Device class	Class II
Decision date	Feb 27, 2019
Decision	Substantially Equivalent
Regulation	892.1200

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Source

View the full FDA submission: accessdata.fda.gov

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uPMR 790

Everything you need for a 510(k) submission. Nothing you don't.