(212 days)
The MX300 is intended to continuously measure and display the concentration of oxygen in gas mixtures used in medical applications such as anesthesia, respiratory therapy, and is intended for adult, pediatric and neonatal populations.
Not Found
The provided text is an FDA 510(k) clearance letter for the MX300 Oxygen Monitor, not a study report. As such, it does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them.
The document only states that the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA determined the MX300 is as safe and effective as a device already on the market, but it does not provide the specific performance data, acceptance criteria, or study details you've requested.
Therefore, I cannot populate the table or provide the requested information. To get this level of detail, one would typically need to refer to the actual 510(k) submission document or a study report conducted by the manufacturer.
§ 868.1720 Oxygen gas analyzer.
(a)
Identification. An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also includes paramagnetic analyzers.(b)
Classification. Class II (performance standards).