[Federal Register: March 8, 2004 (Volume 69, Number 45)]
[Rules and Regulations]               
[Page 10615]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

21 CFR Part 870

[Docket Nos. 1994N-0418 and 1996P-0276]

Medical Devices: Cardiovascular Devices: Reclassification of the 
Arrhythmia Detector and Alarm; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; correction.


SUMMARY: 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.

EFFECTIVE DATE: March 8, 2004

FOR FURTHER INFORMATION CONTACT: Elias Mallis, Center for Devices and 
Radiological Health (HFZ-450), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-441-8571, ext. 177.

SUPPLEMENTARY INFORMATION: In FR Doc. 03-27115, appearing on page 61342 
in the Federal Register of Tuesday, October 28, 2003, the following 
correction is made:

Sec.  870.5310  [Corrected]

On page 61344, in the first column, in Sec.  870.5310 Automated 
external defibrillator, beginning in the seventh line, the 
parenthetical ``(restoring normal hearth rhythm)'' is corrected to read 
``(restoring normal heart rhythm).''

    Dated: February 26, 2004.
Beverly Chernaik Rothstein,
Acting Deputy Director for Policy and Regulations, Center for Devices 
and Radiological Health.
[FR Doc. 04-5045 Filed 3-5-04; 8:45 am]