Optina-4C (MHRC-C1N)— 510(k) K231230

Substantially Equivalent

Optina Diagnostics, Inc.

FDA 510(k) clearance K231230 for Optina-4C (MHRC-C1N), Substantially Equivalent on 2023-12-05. Applicant: Optina Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Optina Diagnostics, Inc.
Product code: Code HKI
Device class: Class 2
Regulation: 21 CFR 886.1120
Advisory panel: Ophthalmic
Date received: 2023-04-28
Decision date: 2023-12-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Montreal, CA

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.