Medrad Continuum MR Compatible Infusion System

• • Terminated Z-0841-05 FDA Unclassified (pre-2012) ·initiated 22 Mar 2005

  Customer complaint that a continuum infusion pump was attracted to an MR scanner due to customer not completely engaging the pump into the bracket.

510(k) Number

K021988 ↗

FDA Product Code

FRN

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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