Mydriatic Hyperspectral Retinal Camera (MHRC-C1)— 510(k) K200254

Substantially Equivalent

Optina Diagnostics

FDA 510(k) clearance K200254 for Mydriatic Hyperspectral Retinal Camera (MHRC-C1), Substantially Equivalent on 2020-04-27. Applicant: Optina Diagnostics.

Clearance details

Applicant: Optina Diagnostics
Product code: Code HKI
Advisory panel: Ophthalmic
Date received: 2020-02-03
Decision date: 2020-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montreal, CA

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