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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ophthalmoscope, Laser, Scanning
510(k) Number K082016
Device Name GDX VCC WITH ECC SOFTWARE
Applicant
Carl Zeiss Meditec, Inc.
5160 Hacienda Dr.
Dublin,  CA  94568
Applicant Contact JUDITH A BRIMACOMBE
Correspondent
Carl Zeiss Meditec, Inc.
5160 Hacienda Dr.
Dublin,  CA  94568
Correspondent Contact JUDITH A BRIMACOMBE
Regulation Number886.1570
Classification Product Code
MYC  
Subsequent Product Code
HLI  
Date Received07/15/2008
Decision Date 08/10/2009
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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