(289 days)
The Morpheus ™ 1 Automated Sleep Study Scoring and Data Management System is a computer program (software) intended for use as an aid for the diagnosis of sleep and respiratory disorders.
The Morpheus ™ 1, Automated Sleep Study Scoring and Data Management System is intended to be used for analysis (automatic scoring and manual re-scoring), display, redisplay (retrieve), summarize, reports generation and networking of data received from monitoring devices typically used to evaluate sleep and respiratory related sleep disorders.
This device is to be used under the supervision of a physician.
The Morpheus™ 1, Automated Sleep Study Scoring and Data Management System is a computer program (software) intended for use as an aid for the diagnosis of sleep and respiratory disorders.
The Morpheus 100 1, Automated Sleep Study Scoring and Data Management System is intended to be used for analysis (automatic scoring and manual rescoring), display, redisplay (retrieve), summarize, reports generation and networking of data received from monitoring devices typically used to evaluate sleep and respiratory related sleep disorders.
This document primarily focuses on the FDA 510(k) clearance for the Morpheus™ 1 Automated Sleep Study Scoring and Data Management System, establishing its substantial equivalence to a predicate device. It does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot provide the requested table and study description based on the provided text. The document is an FDA letter and a declaration of indications for use, not a clinical study 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).