(415 days)
This device intended for use by patients who experience transient symptoms that , may suggest cardiac arrythmia.
The device is not intended for the simultaneous recording and transmitting of the . patient's ECG signals.
Card Guard Model CG-2206 Personal Electrocardiogram Transmitter.
The provided text is a 510(k) clearance letter from the FDA for the Card Guard Model CG-2206 Personal Electrocardiogram Transmitter. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. This type of letter primarily indicates that the device has been deemed substantially equivalent to a legally marketed predicate device, allowing it to be marketed.
Therefore, I cannot provide the requested information from the given text.
To answer your specific questions, I would need a document that describes the design verification and validation studies performed for the device.
§ 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).