[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR892.1540]

[Page 518]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 892--RADIOLOGY DEVICES--Table of Contents
 
                      Subpart B--Diagnostic Devices
 
Sec. 892.1540  Nonfetal ultrasonic monitor.

    (a) Identification. A nonfetal ultrasonic monitor is a device that 
projects a continuous high-frequency sound wave into body tissue other 
than a fetus to determine frequency changes (doppler shift) in the 
reflected wave and is intended for use in the investigation of nonfetal 
blood flow and other nonfetal body tissues in motion. This generic type 
of device may include signal analysis and display equipment, patient and 
equipment supports, component parts, and accessories.
    (b) Classification. Class II.