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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Ophthalmic, Ac-Powered
510(k) Number K062416
Device Name RETINAL FUNCTIONAL IMAGER (RFI)
Applicant
Optical Imaging , Ltd.
555 Thirteenth St. NW
Washington,  DC  20004
Applicant Contact JONATHAN S KAHAN
Correspondent
Optical Imaging , Ltd.
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact JONATHAN S KAHAN
Regulation Number886.1120
Classification Product Code
HKI  
Subsequent Product Code
HLI  
Date Received08/17/2006
Decision Date 11/17/2006
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
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