[Code of Federal Regulations] [Title 21, Volume 8] [Revised as of April 1, 2001] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR870.2330] [Page 295] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued) PART 870--CARDIOVASCULAR DEVICES--Table of Contents Subpart C--Cardiovascular Monitoring Devices Sec. 870.2330 Echocardiograph. (a) Identification. An echocardiograph is a device that uses ultrasonic energy to create images of cardiovascular structures. It includes phased arrays and two-dimensional scanners. (b) Classification. Class II (performance standards). [[Page 296]]