K-number	K190772
Device name	SURGICAL MICROSCOPE SYSTEM ORBEYE with IR
Applicant	Olympus Medical Systems Corp.
Product code	IZI
Device class	Class II
Decision date	Oct 10, 2019
Decision	Substantially Equivalent
Regulation	892.1600

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View the full FDA submission: accessdata.fda.gov

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SURGICAL MICROSCOPE SYSTEM ORBEYE with IR

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