Disinfectant, Subsystem, Water Purification

FDA product code NIH · Class II (moderate risk) · 21 CFR 876.5665 · Gastroenterology, Urology

Disinfectant intended for reprocessing water purification systems for hemodialysis.

1510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K133724Minncare HDNIH · Traditional Medivators, Inc.08/27/2014SE