21 C.F.R. § 868.1920 Esophageal stethoscope with electrical conductors.
Title 21 - Food and Drugs
(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).
Title 21: Food and Drugs
PART 868—ANESTHESIOLOGY DEVICES
Subpart B—Diagnostic Devices
§ 868.1920 Esophageal stethoscope with electrical conductors.
