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

    Capnostream™35 Portable Respiratory Monitor (PM35MN)

    K Number: K253030 · Decision May 1, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    217
    Registration Numbers
    217
    Same Product Code
    304
    Applicant Total
    89
    Review Days
    224

    Basic Information

    Device Name
    Capnostream™35 Portable Respiratory Monitor (PM35MN)
    K Number
    K253030
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1400
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Covidien, LLC
    Date Received
    September 19, 2025
    Decision Date
    May 1, 2026
    Product Code
    CCK
    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
    CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

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