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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Perimeter, Automatic, Ac-Powered
510(k) Number K093213
Device Name GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIES
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 Number886.1605
Classification Product Code
HPT  
Date Received10/13/2009
Decision Date 03/12/2010
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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