(59 days)
The Telemedicine 2000 is a Telemedicine Receiving Center intended for supporting transtelephonic monitoring of ECG parameters of cardiac patients.
Not Found
This FDA 510(k) clearance letter for the "Telemedicine 2000, the Telemedicine Receiving Center" does not contain the detailed information required to fulfill your request. The letter confirms substantial equivalence to a predicate device for the purpose of market clearance, but it does not include any data or descriptions of studies regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement.
The provided text is a regulatory clearance document, not a scientific study report.
Therefore, I cannot provide the requested information, including the table of acceptance criteria and reported device performance, as that data is simply not present in the given input.
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(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).