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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 K053044
Device Name OPTO GLOBAL DIGITAL FUNDUS CAMERA SYSTEM MODEL ADS 1.5
Applicant
OPTO GLOBAL, INC
4021 DAGGETT DRIVE
GRANITE BAY,  CA  95746
Applicant Contact MARK T FUKUHARA
Correspondent
UNDERWRITERS LABORATORIES, INC.
1655 SCOTT BLVD.
SANTA CLARA,  CA  95050
Correspondent Contact LORINDA BADALIAN
Regulation Number886.1120
Classification Product Code
HKI  
Subsequent Product Codes
NFF   NFG  
Date Received10/28/2005
Decision Date 01/24/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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