21 CFR 870.3630
§ 870.3630 Pacemaker generator function analyzer.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 870.3630, § 870.3630 Pacemaker generator function analyzer, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89968
- Permanent ID
ys:prov:89968@1- SHA-256
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Full text
(a) Identification. A pacemaker generator function analyzer is a device that is connected to a pacemaker pulse generator to test any or all of the generator's parameters, including pulse duration, pulse amplitude, pulse rate, and sensing threshold.
(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.