Optomed Smartscope M5 with Optomed Smartscope FA— 510(k) K201325

Name: FDA 510(k) clearance K201325
Creator: U.S. Food and Drug Administration
Published: 2020-11-20

Substantially Equivalent

Optomed Oyj

FDA 510(k) clearance K201325 for Optomed Smartscope M5 with Optomed Smartscope FA, Substantially Equivalent on 2020-11-20. Applicant: Optomed Oyj. Device class: 2.

Clearance details

Applicant: Optomed Oyj
Product code: Code HKI
Device class: Class 2
Regulation: 21 CFR 886.1120
Advisory panel: Ophthalmic
Date received: 2020-05-18
Decision date: 2020-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oulu, FI

Download summary PDF View on FDA.gov ↗

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