OEV · Cardiopulmonary Resuscitation Aid Kit
Anesthesiology · 21 CFR 868.5915 · Class 2
Overview
| Product Code | OEV |
|---|---|
| Device Name | Cardiopulmonary Resuscitation Aid Kit |
| Regulation | 21 CFR 868.5915 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
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.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
