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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name camera, ophthalmic, ac-powered
510(k) Number K122572
Model DRS 16
Device Name ICAM FUNDUS CAMERA
Original Applicant
OPTOVUE, INC.
2800 bayview dr
fremont,  CA  94538
Original Contact azimun jamal
Regulation Number886.1120
Classification Product Code
HKI  
Date Received08/23/2012
Decision Date 01/11/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Ophthalmic
Review Advisory Committee Ophthalmic
summary summary
Type Traditional
Clinical Trials NCT01600261
Reviewed by Third Party No
Expedited Review No
Combination Product No
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