FDA product code QOW

Ventilatory Assistance Helmet

Unknown·Class N·21 CFR
US regulatory classifications
US Product Code (FDA)
QOW
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US Risk Class (FDA)
Class N
US Regulation (CFR)
21 CFR
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Medical specialty
Unknown
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Ventilatory Assistance Helmet is a medical device type in the Unknown specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.