21 CFR § 870.2910
Radiofrequency physiological signal transmitter and receiver
June 25, 2020
(a) Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.
(b) Classification. Class II (performance standards).