[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: 21CFR870.1750]

[Page 298]
 
                        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. 870.1750  External programmable pacemaker pulse generator.

    (a) Identification. An external programmable pacemaker pulse 
generators is a device that can be programmed to produce one or more 
pulses at preselected intervals; this device is used in 
electrophysiological studies.
    (b) Classification. Class II (performance standards).