21 CFR § 870.2920
Telephone electrocardiograph transmitter and receiver
June 25, 2020
(a) Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.
(b) Classification. Class II (performance standards).