21 C.F.R. § 868.1920

Current through October 31, 2024
Section 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).

21 C.F.R. § 868.1920