(30 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 a 510(k) clearance letter from the FDA for the Carnation Ambulatory Monitor. It states the device is substantially equivalent to legally marketed predicate devices but does not contain information on acceptance criteria or studies proving the device meets those criteria. The document focuses on regulatory compliance and the device's indications for use. Therefore, I cannot extract the requested information from the provided text.
§ 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).