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510(k) K180378

Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module by Optomed OY — Product Code HKI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2018
Date Received
February 12, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Ophthalmic, Ac-Powered
Device Class
Class II
Regulation Number
886.1120
Review Panel
OP
Submission Type

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