510(k) K221338

Device

F&P Airvo 3

Applicant

Fisher & Paykel Healthcare

510(k) number

K221338

Product code

QAV

Decision

Substantially Equivalent (SESE)

Decision date

2023-01-27

Date received

2022-05-09

Regulation

868.5454

Classification name

High Flow/High Velocity Humidified Oxygen Delivery Device

Medical specialty

Anesthesiology

Review panel

Anesthesiology

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No