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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Water Purification, General Medical Use
510(k) Number K222727
Device Name i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S)
Applicant
I3 Membrane GmbH
Christoph-Seydel-Strasse 1
Radeberg,  DE 01454
Applicant Contact Stephan Brinke-Seiferth
Correspondent
I3 Membrane GmbH
Theodorstrasse 41p
Hamburg,  DE 22761
Correspondent Contact Thor Hinnerk Meyer
Regulation Number876.5665
Classification Product Code
NHV  
Date Received09/08/2022
Decision Date 06/02/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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