(289 days)
SnoreSounds software is indicated for use as an aid in the diagnostic evaluation of snoring in patients. The software provides quantitative and qualitative analysis of snoring.
Not Found
This document is a 510(k) clearance letter from the FDA for a device called "SnoreSounds." It indicates that the device has been found substantially equivalent to a legally marketed predicate device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to your request.
The letter acknowledges the device (K150102) and its intended use as an aid in the diagnostic evaluation of snoring, providing quantitative and qualitative analysis. The rest of the document is standard FDA regulatory boilerplate, including contact information and references to relevant regulations.
Therefore, I cannot provide the detailed information requested in your prompt based on the provided text.
§ 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).