(199 days)
Plus Reusable Resuscitators are intended for use by trained medical personnel to maintain lung ventilation during resuscitation and other critical situations and when natural breathing is insufficient or absent.
Not Found
I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter for a "Plus Reusable Resuscitator" and primarily discusses the regulatory approval and substantial equivalence to a predicate device. It indicates the device's intended use but does not detail acceptance criteria, performance data, study designs, sample sizes, ground truth establishment, or expert qualifications as typically found in a clinical study report or device performance evaluation.
§ 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).