69 FR 45 pg. 10615 - Medical Devices: Cardiovascular Devices: Reclassification of the Arrhythmia Detector and Alarm; Correction
Type: RULEVolume: 69Number: 45Page: 10615
Docket number: [Docket Nos. 1994N-0418 and 1996P-0276]
FR document: [FR Doc. 04-5045 Filed 3-5-04; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
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:
§ 870.5310 [Corrected]
On page 61344, in the first column, in § 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]
BILLING CODE 4160-01-S