Prisma Cfm (Continuous Fluid Management System)

• • Terminated Z-0705-06 FDA Unclassified (pre-2012) ·initiated 24 Oct 2005

  After dialysis machine is disconnected from the patient, blood leakage may occur while unloading the tubing sets from the machine.

510(k) Number

K981681 ↗

FDA Product Code

KDI

Device Class

Class II

Regulation

21 CFR Part 876.5860

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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See all devices from Gambro Healthcare →