21 C.F.R. § 870.3720 Pacemaker electrode function tester.
Title 21 - Food and Drugs
(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).
Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart D—Cardiovascular Prosthetic Devices
§ 870.3720 Pacemaker electrode function tester.