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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 K101861
Device Name TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM
Applicant
Truevision Systems, Incorporated
114 E. Haley St., Suite L
Santa Barbara,  CA  93101
Applicant Contact BURTON TRIPATHI
Correspondent
Truevision Systems, Incorporated
114 E. Haley St., Suite L
Santa Barbara,  CA  93101
Correspondent Contact BURTON TRIPATHI
Regulation Number886.1120
Classification Product Code
HKI  
Subsequent Product Codes
EPT   NFJ  
Date Received07/02/2010
Decision Date 12/22/2010
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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