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The device is intended for the spot measurement of respiration rate of an adult patient in a home or clinical setting. It is not a vital signs monitor or an apnea monitor. It should not be used on patients that exhibit uncontrolled limb movement.

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The provided text does not contain detailed information about the acceptance criteria, the specific study that proves the device meets the acceptance criteria, or the various aspects of the study design such as sample size, data provenance, expert qualifications, or adjudication methods.

The document is an FDA 510(k) clearance letter for the "Breathe Easy Mobile Respiratory Monitor (MRM)," indicating that the device has been found substantially equivalent to a legally marketed predicate device. It defines the "Indications for Use" for the device, stating it's for "spot measurement of respiration rate of an adult patient in a home or clinical setting. It is not a vital signs monitor or an apnea monitor. It should not be used on patients that exhibit uncontrolled limb movement."

However, it does not provide the specific data requested in your prompt regarding acceptance criteria, performance metrics, or study methodology. This type of detailed technical data is typically found in the 510(k) submission summary or associated technical documentation, which is not included in the provided text.

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