QOU — Emergency Resuscitator Class N
FDA product code QOU covers "Emergency Resuscitator", a Class N medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- QOU
- Device Class
- Class N
- Regulation Number
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Unknown
- Implant
- No
Definition
Emergency ventilator incorporating bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway (may be automated) for use during declared public health emergency.