FDA 510(k) Application Details - K242269

Device Classification Name	Hemodialysis System For Home Use   More FDA Info for this Device
510(K) Number	K242269
Device Name	Hemodialysis System For Home Use
Applicant	Quanta Dialysis Technologies Ltd The Woods Haywood Road Warwick CV34 5AH GB Other 510(k) Applications for this Company
Contact	Sam Drew Other 510(k) Applications for this Contact
Regulation Number	876.5860   More FDA Info for this Regulation Number
Classification Product Code	ONW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/01/2024
Decision Date	11/01/2024
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