 |
Code of Federal Regulations (Last Updated: May 6, 2024) |
 |
Title 21 - Food and Drugs |
|
Chapter I - Food and Drug Administration, Department of Health and Human Services |
|
SubChapter H - Medical Devices |
|
Part 870 - Cardiovascular Devices |
|
Subpart B - Cardiovascular Diagnostic Devices |
§ 870.1270 - Intracavitary phonocatheter system.
Latest version.
-
§ 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).