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

    Fenom Pro

    K Number: K213611 · Decision Jun 7, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    14
    Applicant Total
    1
    Review Days
    569

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    Basic Information

    Device Name
    Fenom Pro
    K Number
    K213611
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3080
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Caire Diagnostics, Inc.
    Date Received
    November 15, 2021
    Decision Date
    June 7, 2023
    Product Code
    MXA
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MXA System, Test, Breath Nitric Oxide

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