[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: 21CFR868.2025]

[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 C_Monitoring Devices
 
Sec. 868.2025  Ultrasonic air embolism monitor.


    (a) Identification. An ultrasonic air embolism monitor is a device 
used to detect air bubbles in a patient's blood stream. It may use 
Doppler or other ultrasonic principles.
    (b) Classification. Class II (performance standards).