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510(k) K142953

OCT-Camera by Optomedical Technologies GmbH — Product Code HLI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 2015
Date Received
October 10, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ophthalmoscope, Ac-Powered
Device Class
Class II
Regulation Number
886.1570
Review Panel
OP
Submission Type

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