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).