(82 days)
Cardiostation is a transtelephonic cardiac monitoring station intended to provide the reception and evaluation of the ECG signal, transmitted via standard telephone lines, using commercially available transtelephonic cardiac monitoring devices. It is intended that the Cardiostation will be used by physicians and cardiac laboratories supervised by physicians.
Cardiostation is a transtelephonic cardiac monitoring station intended to provide the reception and evaluation of the ECG signal, transmitted via standard telephone lines, using commercially available transtelephonic cardiac monitoring devices.
I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, sample sizes, expert qualifications, or study details. This document appears to be an FDA 510(k) clearance letter for a device called "Cardiostation," primarily focusing on its substantial equivalence to a predicate device and its indications for use. It does not include a study report or performance data.
§ 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).