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

    Spectrum-2

    K Number: K254129 · Decision May 22, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    73
    Applicant Total
    2
    Review Days
    151

    Basic Information

    Device Name
    Spectrum-2
    K Number
    K254129
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neko Health AB
    Date Received
    December 22, 2025
    Decision Date
    May 22, 2026
    Product Code
    MUD
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MUD Oximeter, Tissue Saturation

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    Other Clearances by Neko Health AB

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