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

    F&P Evora Full Face Mask

    K Number: K212371 · Decision Mar 18, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    109
    Registration Numbers
    109
    Same Product Code
    449
    Applicant Total
    16
    Review Days
    231

    Basic Information

    Device Name
    F&P Evora Full Face Mask
    K Number
    K212371
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5905
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fisher & Paykel Healthcare Ltd
    Date Received
    July 30, 2021
    Decision Date
    March 18, 2022
    Product Code
    BZD
    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
    BZD Ventilator, Non-Continuous (Respirator)

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