FDA 510(k) Application Details - K211035

Device Classification Name	Subsystem, Water Purification   More FDA Info for this Device
510(K) Number	K211035
Device Name	Subsystem, Water Purification
Applicant	Baxter Healthcare Corporation 25212 W. Illinois Route 120 Round Lake, IL 60073 US Other 510(k) Applications for this Company
Contact	Carina Pforr 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	04/07/2021
Decision Date	10/19/2021
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