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

---
identifier: "/us/fr/04-5045"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Medical Devices: Cardiovascular Devices: Reclassification of the Arrhythmia Detector and Alarm; Correction"
title_number: 0
title_name: "Federal Register"
section_number: "04-5045"
section_name: "Medical Devices: Cardiovascular Devices: Reclassification of the Arrhythmia Detector and Alarm; Correction"
positive_law: false
currency: "2004-03-08"
last_updated: "2004-03-08"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "04-5045"
document_type: "rule"
publication_date: "2004-03-08"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
cfr_references:
  - "21 CFR Part 870"
fr_citation: "69 FR 10615"
fr_volume: 69
docket_ids:
  - "Docket Nos. 1994N-0418 and 1996P-0276"
fr_action: "Final rule; correction."
---

#  [Corrected]

**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

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.