(226 days)
The M201 Mixer is used to deliver a mixture of air and oxygen in conjunction with oxygen hoods, resuscitation bags, masks, and nasal cannulas. The user can adjust the oxygen percentage within a range of 21-100% and the flow rate within a range of 0-30 liters per minute. Additionally, the device monitors the air supply pressure, oxygen supply pressure, battery voltage, and output oxygen percentage.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called the "SK Med M201 Mixer." It is concerned with the regulatory approval of the device and does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
Therefore, I cannot provide the requested information based on the provided text. The document focuses on confirming that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory responsibilities, not on the technical performance study details.
§ 868.5330 Breathing gas mixer.
(a)
Identification. A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.(b)
Classification. Class II (performance standards).