OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2— 510(k) K132186

Name: FDA 510(k) clearance K132186
Creator: U.S. Food and Drug Administration
Published: 2013-12-18

Substantially Equivalent

Optomed OY

FDA 510(k) clearance K132186 for OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2, Substantially Equivalent on 2013-12-18. Applicant: Optomed OY. Device class: 2.

Clearance details

Applicant: Optomed OY
Product code: Code HKI
Device class: Class 2
Regulation: 21 CFR 886.1120
Advisory panel: Ophthalmic
Date received: 2013-07-15
Decision date: 2013-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oulu, FI

Download summary PDF View on FDA.gov ↗

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