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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 K121739
Device Name IVUE WITH NORMATIVE DATABASE
Applicant
OPTOVUE, INC.
45531 Northport Loop W
FREMONT,  CA  94538
Applicant Contact Azimun Jamal
Correspondent
OPTOVUE, INC.
45531 Northport Loop W
FREMONT,  CA  94538
Correspondent Contact Azimun Jamal
Regulation Number886.1570
Classification Product Code
HLI  
Date Received06/13/2012
Decision Date 01/18/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Clinical Trials NCT01459731
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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