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

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.

Clearance details

Applicant: Optomed OY
Product code: Code HKI
Advisory panel: Ophthalmic
Date received: 2018-02-12
Decision date: 2018-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oulu, FI

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