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510(k) K221338

F&P Airvo 3 by Fisher & Paykel Health Care — Product Code QAV

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 27, 2023
Date Received: May 9, 2022
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: High Flow/High Velocity Humidified Oxygen Delivery Device
Device Class: Class II
Regulation Number: 868.5454
Review Panel: AN
Submission Type

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