K-number	K161194
Device name	PLEX Elite 9000 SS-OCT
Applicant	Carl Zeiss Meditec, Inc.
Product code	OBO
Device class	Class II
Decision date	Oct 26, 2016
Decision	Substantially Equivalent
Regulation	886.1570

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View the full FDA submission: accessdata.fda.gov

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PLEX Elite 9000 SS-OCT

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