FDA 510(k) Applications for Medical Device Product Code: ONW (Hemodialysis System For Home Use)

FDA 510(k) Applications for Medical Device Product Code "ONW"
(Hemodialysis System For Home Use)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K124035	FRESENIUS MEDICAL CARE NORTH AMERICA	2008K@HOME HEMODIALYSIS MACHINE	07/03/2013
K070049	FRESENIUS MEDICAL CARE NORTH AMERICA	FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR	02/03/2011
K121421	FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE	FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT)	01/17/2013
K242269	Quanta Dialysis Technologies Ltd	SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651)	11/01/2024