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