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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 K990205
Device Name DIGISCOPE OPHTHALMIC CAMERA
Applicant
Eye Tel Imaging, Inc.
15078 Stillfield Pl.
Centreville,  VA  20120
Applicant Contact KEVIN T QUINN
Correspondent
Eye Tel Imaging, Inc.
15078 Stillfield Pl.
Centreville,  VA  20120
Correspondent Contact KEVIN T QUINN
Regulation Number886.1120
Classification Product Code
HKI  
Date Received01/21/1999
Decision Date 03/26/1999
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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