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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 K100861
Device Name R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100
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 Received03/26/2010
Decision Date 06/17/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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