21 CFR § 870.3720 Cardiovascular Devices

§ 870.3720 Pacemaker electrode function tester.

Current through Sep 8, 2026 · Read all of Part 870

⚠ 3 pending changes to Part 870

(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).

← § 870.3710 Pacemaker repair or replacement material.§ 870.3730 Pacemaker service tools. →