ODX · Class II · 21 CFR 876.5820

FDA Product Code ODX: Autonomous Extracorporeal Blood Leak Detector/alarm

To Detect The Presence Of Blood Leaking From An Extracorporeal Connection Or Needle Site In Hemodialysis Patients And Alert The User Or Attending Staff. The Device Detects Colormetric, Chemical, Or Light Modulation Caused By Exposure To Leaking Blood.

4
Total
4
Cleared
195d
Avg days
2007
Since

FDA 510(k) Cleared Autonomous Extracorporeal Blood Leak Detector/alarm Devices (Product Code ODX)

4 devices
1–4 of 4
No devices found for this product code.

About Product Code ODX - Regulatory Context