21 CFR 870.3720
§ 870.3720 Pacemaker electrode function tester.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 870.3720, § 870.3720 Pacemaker electrode function tester, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89976
- Permanent ID
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Full text
(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).
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.