Spectralis HRA+OCT and Variants— 510(k) K192391

Substantially Equivalent

Heidelberg Engineering GmbH

FDA 510(k) clearance K192391 for Spectralis HRA+OCT and Variants, Substantially Equivalent on 2019-09-26. Applicant: Heidelberg Engineering GmbH.

Clearance details

Applicant: Heidelberg Engineering GmbH
Product code: Code OBO
Advisory panel: Ophthalmic
Date received: 2019-09-03
Decision date: 2019-09-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Heidelberg, DE

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