NII · Class II · 21 CFR 876.5860

FDA Product Code NII: Disinfectant, Dialysate Delivery System

Disinfectant Intended For Reprocessing Dialysate Delivery Systems.

Leading manufacturers include Krd Co., Ltd. and Ge Infrastructure Water & Process Technologies.

2
Total
2
Cleared
459d
Avg days
2004
Since

FDA 510(k) Cleared Disinfectant, Dialysate Delivery System Devices (Product Code NII)

2 devices
1–2 of 2
Cleared Nov 04, 2005
OZONE GENERATOR
K043207
Ge Infrastructure Water & Process Technologies
General Hospital · 350d
Cleared Apr 06, 2004
HEMOCLEAN
K023064
Krd Co., Ltd.
General Hospital · 568d

About Product Code NII - Regulatory Context