BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50

    K Number: K202480 · Decision Apr 22, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    54
    Applicant Total
    1
    Review Days
    237

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    Basic Information

    Device Name
    Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50
    K Number
    K202480
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5330
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Parker Hannifin
    Date Received
    August 28, 2020
    Decision Date
    April 22, 2021
    Product Code
    BZR
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    BZR Mixer, Breathing Gases, Anesthesia Inhalation

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