Atlas FDA

QAV

3 FDA 510(k) clearances · Product code

FDA profile

Official device name
High Flow/High Velocity Humidified Oxygen Delivery Device
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5454
Medical specialty
Anesthesiology
FDA definition
Intended to deliver high flow and/or high velocity oxygen with humidification.
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RecordFirmDate
F&P Airvo 3 (K221338)Fisher & Paykel Healthcare2023-01-27
HVT 2.0 (K221318)Vapotherm, Inc.2022-12-13
Precision Flow® HVNI (DEN170001)Vapotherm, Inc.2018-04-10

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Every clearance here is in the API, with alerts when new ones post.