Code of Federal Regulations · Section

§ 870.3720 — Pacemaker Electrode Function Tester

21 C.F.R. § 870.3720

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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).

21 C.F.R. § 870.3710 21 C.F.R. § 870.3730

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