21 C.F.R. § 870.1750
External programmable pacemaker pulse generator.
Cite as 21 C.F.R. § 870.1750 (2026)
(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).