[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: 21CFR870.1270]

[Page 304]
 
                        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 B--Cardiovascular Diagnostic Devices
 
Sec. 870.1270  Intracavitary phonocatheter system.

    (a) Identification. An intracavitary phonocatheter system is a 
system that includes a catheter with an acoustic transducer and the 
associated device that processes the signal from the transducer; this 
device records bioacoustic phenomena from a transducer placed within the 
heart, blood vessels, or body cavities.
    (b) Classification. Class II (performance standards).