BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇪 Sweden

    Air Next

    K Number: K183089 · Decision Jan 2, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    227
    Applicant Total
    2
    Review Days
    422

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    Basic Information

    Device Name
    Air Next
    K Number
    K183089
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1840
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nuvoair AB
    Date Received
    November 6, 2018
    Decision Date
    January 2, 2020
    Product Code
    BZG
    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
    BZG Spirometer, Diagnostic

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    Other Clearances by Nuvoair AB

    K Number Device Name
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