(189 days)
The Ultima Snoring Mike provides a qualitative measure of snoring for recording onto an FDA-cleared data acquisition system.
Not Found
The provided document is an FDA 510(k) clearance letter for the "Ultima Snoring Mike, Model 0540." This type of document declares substantial equivalence to a predicate device and permits marketing. It does not contain specific details about acceptance criteria or a dedicated study proving the device meets those criteria, as typically found in clinical study reports or detailed technical documentation.
Therefore, I cannot provide the requested information from the given text.
The document primarily states:
- The device name and model.
- Its classification (Class II, Product Code MNR).
- Its intended use: "provides a qualitative measure of snoring for recording onto an FDA-cleared data acquisition system."
- Target population and environment of use.
- Concurrence of the FDA's Office of Device Evaluation.
This document serves as an authorization to market the device, not a detailed technical report of its performance against specific acceptance criteria.
§ 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).