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QAV — High Flow/High Velocity Humidified Oxygen Delivery Device Class II

FDA Device Classification

Classification Details

Product Code
QAV
Device Class
Class II
Regulation Number
868.5454
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Definition

Intended to deliver high flow and/or high velocity oxygen with humidification.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K221338fisher and paykel health careF&P Airvo 3January 27, 2023
K221318vapothermHVT 2.0December 13, 2022
DEN170001vapothermPrecision Flow® HVNIApril 10, 2018