BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇿 New Zealand

    F&P myAirvo 3

    K Number: K222292 · Decision May 8, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    108
    Registration Numbers
    108
    Same Product Code
    220
    Applicant Total
    5
    Review Days
    649

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    Basic Information

    Device Name
    F&P myAirvo 3
    K Number
    K222292
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5450
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fisher & Paykel Healthcare
    Date Received
    July 29, 2022
    Decision Date
    May 8, 2024
    Product Code
    BTT
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BTT Humidifier, Respiratory Gas, (Direct Patient Interface)

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    Other Clearances by Fisher & Paykel Healthcare

    K Number Device Name
    K220703 F&P 950 Respiratory Humidifier
    K221338 F&P Airvo 3
    K162553 AirSpiral Heated Breathing Tube
    K162582 HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit