Code of Federal Regulations (alpha)

CFR /  Title 21  /  Part 868  /  Sec. 868.1920 Esophageal stethoscope with electrical conductors.

(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).