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

Name: FDA 510(k) clearance K200254
Creator: U.S. Food and Drug Administration
Published: 2020-04-27

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. Device class: 2.

Clearance details

Applicant: Optina Diagnostics
Product code: Code HKI
Device class: Class 2
Regulation: 21 CFR 886.1120
Advisory panel: Ophthalmic
Date received: 2020-02-03
Decision date: 2020-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montreal, CA

Download summary PDF View on FDA.gov ↗

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