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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tomography, Optical Coherence
510(k) Number K161194
Device Name PLEX Elite 9000 SS-OCT
Applicant
Carl Zeiss Meditec, Inc.
5160 Hacienda Dr.
Dublin,  CA  94568
Applicant Contact CHRISTINE DUNBAR
Correspondent
Carl Zeiss Meditec, Inc.
5160 Hacienda Dr.
Dublin,  CA  94568
Correspondent Contact CHRISTINE DUNBAR
Regulation Number886.1570
Classification Product Code
OBO  
Subsequent Product Code
HJO  
Date Received04/27/2016
Decision Date 10/26/2016
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
Recalls CDRH Recalls
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