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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
FOIA Releasable 510(k) K120238
Device Name RTVUE XR OCT
Applicant
Optovue, Inc.
45531 Northport Loop W
Fremont,  CA  94538
Applicant Contact JOHN J TALARICO
Correspondent
Optovue, Inc.
45531 Northport Loop W
Fremont,  CA  94538
Correspondent Contact JOHN J TALARICO
Regulation Number886.1570
Classification Product Code
HLI  
Date Received01/26/2012
Decision Date 04/03/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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