ONW

Hemodialysis System For Home Use

Product code

ONW

Device name

Hemodialysis System For Home Use

Device class

Class 2

21 CFR

21 CFR 876.5860

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

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

FDA classification definition

To treat and provide hemodialysis therapy at home for chronic renal failure patients.

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

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-11-01.

1 summaries are archived here for direct download.