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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope, Neurological
510(k) Number K232159
Device Name QEVO System
Applicant
Carl Zeiss Meditec, AG
Rudolf-Eber-Strasse 11
Oberkochen,  DE 73447
Applicant Contact Eva Jankovics
Correspondent
Carl Zeiss Meditec, Inc.
5300 Central Pkwy.
Dublin,  CA  94568
Correspondent Contact Chaitali Gawde
Regulation Number882.1480
Classification Product Code
GWG  
Date Received07/20/2023
Decision Date 09/21/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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