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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilizer, Steam
510(k) Number K214120
Device Name GSS610N21 Series Steam Sterilizer
Applicant
Maquet GmbH
Kehler Strasse 31
Rastatt,  DE 76437
Applicant Contact Holger Ullrich
Correspondent
Getinge
45 Barbour Pond
Wayne,  NJ  07470
Correspondent Contact Barb Smith
Regulation Number880.6880
Classification Product Code
FLE  
Date Received12/30/2021
Decision Date 05/18/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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