---
kind: "section"
citation: "21 C.F.R. § 870.1025"
title: "21"
number: "870.1025"
heading: "Arrhythmia detector and alarm (including ST-segment measurement and alarm)."
url: "https://uscodex.org/cfr/21/870.1025"
---

# §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](/cfr/21/870.1.md) for the availability of this guidance document.

## Notes

### Amendments

[68 FR 61344, Oct. 28, 2003]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

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

### Amendments

[68 FR 61344, Oct. 28, 2003]