TITLE 21 - FOOD AND DRUGS

CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H - MEDICAL DEVICES

PART 868 - ANESTHESIOLOGY DEVICES

subpart b - DIAGNOSTIC DEVICES

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).