(a) Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.
(b) Classification. Class II (special controls). The guidance document entitled ``Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm'' will serve as the special control. See Sec. 870.1 for the availability of this guidance document. [68 FR 61344, Oct. 28, 2003]