(196 days)
The CG-6550 is a Personal 3-Lead Electrocardiogram (ECG) Transmitter intended for long-term monitoring of cardiac patients, for detection of rhythm disorders and ST-changes.
Card Guard Model CG-6550 Personal 3-Lead ECG Transmitter.
The provided text is a 510(k) premarket notification letter from the FDA regarding the Card Guard Personal ECG Transmitter Model CG-6550. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
The letter is a regulatory document confirming that the FDA has determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It does not include the technical details of the device's validation.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided 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).