SPECTRALIS HRA+OCT and variants— 510(k) K223557

Substantially Equivalent

Heidelberg Engineering GmbH

FDA 510(k) clearance K223557 for SPECTRALIS HRA+OCT and variants, Substantially Equivalent on 2023-10-20. Applicant: Heidelberg Engineering GmbH.

Clearance details

Applicant: Heidelberg Engineering GmbH
Product code: Code OBO
Advisory panel: Ophthalmic
Date received: 2022-11-25
Decision date: 2023-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Heidelberg, DE

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