§ 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).