K-number	K192391
Device name	Spectralis HRA+OCT and Variants
Applicant	Heidelberg Engineering GmbH
Product code	OBO
Device class	Class II
Decision date	Sep 26, 2019
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

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