21 CFR § 868.1920
Esophageal stethoscope with electrical conductors
June 25, 2020
(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).