FDA 510(k) Application Details - K232283

Device Classification Name	System, Hemodialysis, Access Recirculation Monitoring   More FDA Info for this Device
510(K) Number	K232283
Device Name	System, Hemodialysis, Access Recirculation Monitoring
Applicant	Physician Software Systems, LLC 3333 Warrenville Road, Suite 200 Lisle, IL 60532 US Other 510(k) Applications for this Company
Contact	Lewis Mitchell Other 510(k) Applications for this Contact
Regulation Number	876.5820   More FDA Info for this Regulation Number
Classification Product Code	MQS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/31/2023
Decision Date	12/14/2023
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