U.S. Code of Federal Regulations
Regulations most recently checked for updates: Oct 07, 2025
(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).