21 CFR 870.1025 - Arrhythmia detector and alarm (including ST-segment measurement and alarm).

Regulations last checked for updates: Feb 16, 2025

Title 21 - Food and Drugs last revised: Feb 03, 2025

View all text of Subpart B [§ 870.1025 - § 870.1915]

§ 870.1025 - Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(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.

[68 FR 61344, Oct. 28, 2003]

authority: 21 U.S.C. 351,360,360c,360e,360j,360

source: 45 FR 7907, Feb. 5, 1980, unless otherwise noted.

cite as: 21 CFR 870.1025