(60 days)
The M201Plus 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.
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I am sorry, but based on the provided text, there is no information about acceptance criteria, a study that proves a device meets acceptance criteria, sample sizes, data provenance, ground truth establishment, or any information related to AI or multi-reader multi-case studies.
The document is a 510(k) premarket notification letter from the FDA to SK Med, Incorporated, concerning their SK Med M201 Plus Mixer, classified as a Breathing Gas Mixer. It primarily discusses the substantial equivalence determination of the device and regulatory compliance requirements.
Therefore, I cannot provide the requested table and information.
§ 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).