21 C.F.R. § 870.3720
Pacemaker electrode function tester.
Cite as 21 C.F.R. § 870.3720 (2026)
(a) Identification. A pacemaker electrode function tester is a device which is connected to an implanted pacemaker lead that supplies an accurately calibrated, variable pacing pulse for measuring the patient's pacing threshold and intracardiac R-wave potential. (b) Classification. Class II (performance standards).