[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR870.1025]

[Page 295]
 
                        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.


    (a) Identification. An arrhythmia detector and alarm is a system 
that monitors the electrocardiogram and is designed to produce a visible 
or audible signal or alarm when an atrial or ventricular arrhythmia, 
such as a premature contraction or ventricular fibrillation, exists.
    (b) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of a PDP is required. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 870.3.

[45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987]