Name: Predicase
Price: 199 USD

K-number	K111157
Device name	CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION CELL NORMATIVE DATABASES
Applicant	Carl Zeiss Meditec, Inc.
Product code	OBO
Device class	Class II
Decision date	Jan 19, 2012
Decision	Substantially Equivalent
Regulation	886.1570

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Source

View the full FDA submission: accessdata.fda.gov

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CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION CELL NORMATIVE DATABASES

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