Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module— 510(k) K180378

Name: FDA 510(k) clearance K180378
Creator: U.S. Food and Drug Administration
Published: 2018-04-05

Substantially Equivalent

Optomed OY

FDA 510(k) clearance K180378 for Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module, Substantially Equivalent on 2018-04-05. 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: 2018-02-12
Decision date: 2018-04-05
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.