(276 days)
The Bawmed E-Z Bag Resuscitators are manual resuscitators incorporating a bag and valve, intended to provide respiratory support to patients suffering from respiratory distress. The infant model is intended for patients weighing between 5 to 12 kgs, the child model is intended for patients weighing between 10 to 30 kgs, and the adult model is intended for patients weighing more than 30 kgs approximate weight. The Bawmed E-Z Bag Resuscitator provided in reusable models and in the disposable models.
manual resuscitators incorporating a bag and valve
This document is a 510(k) clearance letter for the Bawmed E-Z Bag Resuscitator, an emergency manual ventilator. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as it is a regulatory clearance document, not a scientific study report.
Therefore, I cannot provide the requested information based on the provided text. The document confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. This determination is based on the information submitted by the manufacturer in their 510(k) premarket notification, which would have included performance data, but that specific data and acceptance criteria are not detailed in this clearance letter.
§ 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).