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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
Recalls CDRH Recalls
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