(28 days)
The eCARD is a prescription only single patient use, event recording ECG monitor that can be worn for up to 30 days. It is indicated for use on patients who experience transient symptoms such as syncope, palpitations, shortness of breath, or chest pains.
The cCARD is a prescription only single patient use, continuous recording ECG monitor that can be worn for up to 7 days. It is indicated for use on patients who experience transient symptoms such as syncope, palpitations, shortness of breath, or chest pains.
Not Found
The provided document is an FDA 510(k) clearance letter for the iRhythm Technologies eCARD and cCARD devices. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. The document is primarily a regulatory approval and lists the "Indications for Use" for the devices.
Therefore, I cannot provide the requested information based on the given text.
§ 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).