Zdrowie i gospodarka · 28/10/2003

FDA Reclassifies Arrhythmia Detector and Alarm Devices from Class III to Class II

The Food and Drug Administration (FDA) is reclassifying arrhythmia detector and alarm devices from class III to class II (special controls) based on new information submitted by Health Industry Manufacturers Association (now known as Advamed), Quinton Instrument Co., and Zymed Medical Instrumentation, to monitor electrocardiograms and produce visible or audible signals or alarms for atrial or ventricular arrhythmias.