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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ophthalmoscope, ac-powered
510(K) Number K120238
Model RTVUE XR
Device Name RTVUE XR OCT
Applicant
OPTOVUE, INC.
45531 northport loop w
fremont,  CA  94538
Contact john j talarico
Regulation Number886.1570
Classification Product Code
HLI  
Date Received01/26/2012
Decision Date 04/03/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Ophthalmic
Review Advisory Committee Neurology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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