[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR868.1920]

[Page 299]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 868_ANESTHESIOLOGY DEVICES--Table of Contents
 
                      Subpart B_Diagnostic Devices
 
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).