(250 days)
The PSDR system is a physiological recorder intended to display and to record for later playback of thoracic and abdominal respiratory effort, airflow, oxygen saturation, pulse rate, and a 0-1 volt DC signal (such as CPAP pressure) on the auxiliary input. The PSDR is designed to be used in a supervised (hospital/institutional) or unsupervised (home) environment.
Portable Sleep Data Recorder
The provided text is a 510(k) premarket notification letter from the FDA regarding a "Portable Sleep Data Recorder." It confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed. However, the document does NOT contain any information about acceptance criteria, device performance results, sample sizes for testing or training, expert qualifications, ground truth establishment methods, or whether MRMC or standalone studies were conducted.
Therefore, I cannot provide the requested table and study details. The letter is a regulatory approval document, not a technical performance report.
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).