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510(k) K222292

F&P myAirvo 3 by Fisher & Paykel Health Care — Product Code BTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2024
Date Received
July 29, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5450
Review Panel
AN
Submission Type

Other clearances by Fisher & Paykel Health Care

  • K220703 — F&P 950 Respiratory Humidifier (June 16, 2023)
  • K221338 — F&P Airvo 3 (January 27, 2023)
  • K162553 — AirSpiral Heated Breathing Tube (December 20, 2018)
  • K162582 — HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit (June 23, 2017)

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