[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR870.1025]

[Page 317]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 870_CARDIOVASCULAR DEVICES--Table of Contents
 
               Subpart B_Cardiovascular Diagnostic Devices
 
Sec. 870.1025  Arrhythmia detector and alarm 
(including ST-segment measurement and alarm).


    (a) Identification. The arrhythmia detector and alarm device 
monitors an electrocardiogram and is designed to produce a visible or 
audible signal or alarm when atrial or ventricular arrhythmia, such as 
premature contraction or ventricular fibrillation, occurs.
    (b) Classification. Class II (special controls). The guidance 
document entitled ``Class II Special Controls Guidance Document: 
Arrhythmia Detector and Alarm'' will serve as the special control. See 
Sec. 870.1 for the availability of this guidance document.

[68 FR 61344, Oct. 28, 2003]