Name: Predicase
Price: 199 USD

K-number	K172649
Device name	Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor
Applicant	Heidelberg Engineering GmbH
Product code	OBO
Device class	Class II
Decision date	Nov 1, 2017
Decision	Substantially Equivalent
Regulation	886.1570

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor

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