21 CFR 870.1025
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 870.1025, § 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm), United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89868
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.