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

    F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version

    K Number: K191624 · Decision Mar 9, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    24
    Applicant Total
    8
    Review Days
    265

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    Basic Information

    Device Name
    F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version
    K Number
    K191624
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fisher & Paykel Healthcare Limited
    Date Received
    June 18, 2019
    Decision Date
    March 9, 2020
    Product Code
    MNT
    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
    MNT Sv70 Ventilator

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