FDA 510(k) Application Details - K222727

Device Classification Name	System, Water Purification, General Medical Use   More FDA Info for this Device
510(K) Number	K222727
Device Name	System, Water Purification, General Medical Use
Applicant	i3 Membrane GmbH Christoph-Seydel-Strasse 1 Radeberg 01454 DE Other 510(k) Applications for this Company
Contact	Stephan Brinke-Seiferth Other 510(k) Applications for this Contact
Regulation Number	876.5665   More FDA Info for this Regulation Number
Classification Product Code	NHV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/08/2022
Decision Date	06/02/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review