Name: Predicase
Price: 199 USD

K-number	K182569
Device name	Spectralis HRA+OCT and variants with High Magnification Module
Applicant	Heidelberg Engineering GmbH
Product code	OBO
Device class	Class II
Decision date	Oct 18, 2018
Decision	Substantially Equivalent
Regulation	886.1570

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Source

View the full FDA submission: accessdata.fda.gov

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Spectralis HRA+OCT and variants with High Magnification Module

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