(441 days)
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.
§ 868.5915 Manual emergency ventilator.
(a)
Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).