21 C.F.R. § 870.3720

Current through November 30, 2024
Section 870.3720 - Pacemaker electrode function tester
(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