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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Management, Ophthalmic
510(k) Number K141297
Device Name FORUM GLAUCOMA WORKPLACE
Applicant
Carl Zeiss Meditec, AG
5160 Hacienda Dr.
Dublin,  CA  94568
Applicant Contact MANDY AMBRECHT
Correspondent
Carl Zeiss Meditec, AG
5160 Hacienda Dr.
Dublin,  CA  94568
Correspondent Contact MANDY AMBRECHT
Regulation Number892.2050
Classification Product Code
NFJ  
Date Received05/19/2014
Decision Date 10/03/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
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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