21 CFR 870.3640
§ 870.3640 Indirect pacemaker generator function analyzer.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 870.3640, § 870.3640 Indirect pacemaker generator function analyzer, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89969
- Permanent ID
ys:prov:89969@1- SHA-256
aff64f017c0ac5c3cf2a382c8d80cb0b710460c46cb7536d061bd0d3f72b5399
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Full text
(a) Identification. An indirect pacemaker generator function analyzer is an electrically powered device that is used to determine pacemaker function or pacemaker battery function by periodically monitoring an implanted pacemaker's pulse rate and pulse width. The device is noninvasive, and it detects pacemaker pulse rate and width via external electrodes in contact with the patient's skin.
(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.