FDA 510(k) Application Details - K232953

Device Classification Name	Subsystem, Water Purification   More FDA Info for this Device
510(K) Number	K232953
Device Name	Subsystem, Water Purification
Applicant	Fresenius Medical Care Renal Therapies Group, LLC 920 Winter Street Walthan, MA 02451 US Other 510(k) Applications for this Company
Contact	Greg Calder Other 510(k) Applications for this Contact
Regulation Number	876.5665   More FDA Info for this Regulation Number
Classification Product Code	FIP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/21/2023
Decision Date	06/13/2024
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