(88 days)
The Carnation Ambulatory Monitor is designed to provide extended duration cardiac monitoring for people who are suspected of having cardiac arrhythmias.
Not Found
The provided text is an FDA 510(k) clearance letter for the Carnation Ambulatory Monitor. It does not contain information about the acceptance criteria or any study details that would allow me to populate the requested table and answer the specific questions about the device's performance, ground truth establishment, or study methodologies.
The document only states that the device is "substantially equivalent" to legally marketed predicate devices and outlines the "Indications for Use" for the Carnation Ambulatory Monitor: "The Carnation Ambulatory Monitor is designed to provide extended duration cardiac monitoring for people who are suspected of having cardiac arrhythmias."
To provide the information requested, I would need access to the actual 510(k) submission summary or a separate study report detailing the performance evaluation of the device.
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).