K-number	K182207
Device name	TR90BH
Applicant	Minxray, Inc.
Product code	IZL
Device class	Class II
Decision date	Dec 14, 2018
Decision	Substantially Equivalent
Regulation	892.1720

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Source

View the full FDA submission: accessdata.fda.gov

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TR90BH

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