# Medical Devices: Cardiovascular Devices: Reclassification of the Arrhythmia Detector and Alarm; Correction
> **Food and Drug Administration** · Final rule; correction. · Published 2004-03-08 · 69 FR 10615
## Document
- **Document number:** 04-5045
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 69 FR 10615
- **CFR reference:** 21 CFR 870
- **Publication date:** 2004-03-08
- **HHS docket:** Docket Nos. 1994N-0418 and 1996P-0276
## Abstract

The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of October 28, 2003 (68 FR 61342). That document issued a final rule reclassifying arrhythmia detector and alarm devices from class III to class II (special controls). This device is used to monitor an electrocardiogram (ECG) and to produce a visible or audible signal or alarm when an atria or ventricular arrhythmia occurs. The document published with an inadvertent error. This document corrects that error.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2004/03/08/04-5045/medical-devices-cardiovascular-devices-reclassification-of-the-arrhythmia-detector-and-alarm)
---
*AI Analytics · CC0 1.0*