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

    Masimo Stork

    K Number: K234021 · Decision May 3, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    1
    Applicant Total
    85
    Review Days
    135

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    Basic Information

    Device Name
    Masimo Stork
    K Number
    K234021
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2705
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Masimo Corporation
    Date Received
    December 20, 2023
    Decision Date
    May 3, 2024
    Product Code
    QYU
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QYU Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use

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