21 CFR § 868.1920 - Esophageal stethoscope with electrical conductors.

§ 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).