Code of Federal Regulations Title 21. Food and Drugs § 21.870.1025 Arrhythmia detector and alarm (including ST–segment measurement and alarm)
Current as of October 02, 2022 | Updated by FindLaw Staff
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(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 § 870.1 for the availability of this guidance document.
Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.870.1025 Arrhythmia detector and alarm (including ST–segment measurement and alarm) - last updated October 02, 2022 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-870-1025.html
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