21 C.F.R. § 868.1920
Esophageal stethoscope with electrical conductors.
Cite as 21 C.F.R. § 868.1920 (2026)
(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).