21 C.F.R. § 870.1270

Current through October 31, 2024
Section 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).

21 C.F.R. § 870.1270