Medical Devices: Cardiovascular Devices: Reclassification of the Arrhythmia Detector and Alarm; Correction
fda-device · Food and Drug Administration · Rule · Published 2004-03-08 · 69 FR 10615
Document
Document number
04-5045
Federal Register citation
69 FR 10615
CFR reference
21 CFR 870
Type
Rule
Action
Final rule; correction.
Category
fda-device
Sub-agency
Food and Drug Administration
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.