21 CFR 868.1920
§ 868.1920 Esophageal stethoscope with electrical conductors.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 868.1920, § 868.1920 Esophageal stethoscope with electrical conductors, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89739
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Full text
(a) Identification. An esophageal stethoscope with electrical conductors is a device that is inserted into the esophagus to listen to a patient's heart and breath sounds and to monitor electrophysiological signals. The device may also incorporate a thermistor for temperature measurement.
(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.