QOW — Ventilatory Assistance Helmet Class N
FDA product code QOW covers "Ventilatory Assistance Helmet", a Class N medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- QOW
- Device Class
- Class N
- Regulation Number
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Unknown
- Implant
- No
Definition
Patient interface for delivery of positive pressure to assist patient's breathing during declared public health emergency. Can be used with continuous and non-continuous ventilators, wall gas source, oxygen source, humidified gases.