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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 K083291
Device Name CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER AND MACULAR NORMATIVE DATABASES, MODEL 4000
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
OBO  
Date Received11/07/2008
Decision Date 05/05/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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