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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 K231676
Device Name CALLISTO eye
Applicant
Carl Zeiss Meditec, AG
Goeschwitzer Strasse 51-52
Jena,  DE 07745
Applicant Contact Hans-Joachim Miesner
Correspondent
Carl Zeiss Meditec, Inc.
5300 Central Pkwy.
Dublic,  CA  94568
Correspondent Contact Aditya Rao
Regulation Number892.2050
Classification Product Code
NFJ  
Date Received06/09/2023
Decision Date 08/28/2023
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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