21 C.F.R. § 870.1750 External programmable pacemaker pulse generator.
Title 21 - Food and Drugs
(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).
Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart B—Cardiovascular Diagnostic Devices
§ 870.1750 External programmable pacemaker pulse generator.