K-number	K240221
Device name	SPECTRALIS HRA+OCT and variants
Applicant	Heidelberg Engineering GmbH
Product code	OBO
Device class	Class II
Decision date	Jul 1, 2024
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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