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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K192921
Device Name Zeos Aqua Vision Pump and tube
Applicant
Hemodia Sas
France
Labege,  FR 31670
Applicant Contact Adeline Theron
Correspondent
Visamed GmbH
Kastellstr.8
Karlsruhe,  DE 76227
Correspondent Contact Arne Briest
Regulation Number888.1100
Classification Product Code
HRX  
Date Received10/16/2019
Decision Date 10/09/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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