NIH

Disinfectant, Subsystem, Water Purification

Product code

NIH

Device name

Disinfectant, Subsystem, Water Purification

Device class

Class 2

21 CFR

21 CFR 876.5665

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K) Exempt

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

Disinfectant intended for reprocessing water purification systems for hemodialysis.

Definition text from the FDA device classification database (U.S. federal government work, public domain).