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The Merlin Medical Limited Merlin E-Mask Air Pulmonary Resuscitator is indicated for mouth to mask ventilation of a non-breathing adult and child weighing over 30 kgs.

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I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA to Merlin Medical Limited regarding their Merlin E-Mask. This document does not contain any information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for device performance. It only states that the device is substantially equivalent to a legally marketed predicate device and outlines regulatory compliance requirements.

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The Merlin Resuscitators are manual resuscitators incorporating a bag and valve. They are intended for use in providing artificial respiration to patients suffering from respiratory distress. The infant model is intended for patients weighing between 5 and 12 kg, the child model for patients weighing between 12 and 30 kg, and the adult model is intended for patients weighing more than 30 kg. The Merlin Resuscitator is available in reusable and in disposable models.

Manual resuscitators incorporating a bag and valve.

This document is a 510(k) premarket notification letter for the Merlin Resuscitator. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. It confirms the FDA's determination of substantial equivalence to a predicate device. Therefore, I cannot provide the requested information based on this input.

Ask a specific question about this device