Optina-4C (MHRC-C1N)— 510(k) K250770

Substantially Equivalent

Optina Diagnostics, Inc.

FDA 510(k) clearance K250770 for Optina-4C (MHRC-C1N), Substantially Equivalent on 2025-09-04. Applicant: Optina Diagnostics, Inc..

Clearance details

Applicant: Optina Diagnostics, Inc.
Product code: Code HKI
Advisory panel: Ophthalmic
Date received: 2025-03-13
Decision date: 2025-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montreal, CA

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