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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 K133892
Device Name IVUE 500
Applicant
OPTOVUE, INC.
2800 BAYVIEW DRIVE
FREMONT,  CA  94538
Applicant Contact MICHAEL J SARRASIN
Correspondent
OPTOVUE, INC.
2800 BAYVIEW DRIVE
FREMONT,  CA  94538
Correspondent Contact MICHAEL J SARRASIN
Regulation Number886.1570
Classification Product Code
HLI  
Date Received12/20/2013
Decision Date 03/19/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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