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

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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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

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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.

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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:

[Corrected]
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On page 61344, in the first column, in § 870.5310

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Dated: February 26, 2004.

Beverly Chernaik Rothstein,

Acting Deputy Director for Policy and Regulations, Center for Devices and Radiological Health.

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[FR Doc. 04-5045 Filed 3-5-04; 8:45 am]

BILLING CODE 4160-01-S