Pacemaker electrode function tester.

21 C.F.R. § 870.3720
in effectEffective: 2024-07-01
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(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).

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