21 C.F.R. § 870.3720

Pacemaker electrode function tester.

Last amended: 2016Year: 2026Length: 42 wordsSubsections: 1Official source

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).
21 C.F.R. § 870.3720: Pacemaker electrode function tester. | Justis AI