BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇧🇪 Belgium

    Sunrise

    K Number: K250874 · Decision Aug 29, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    158

    Basic Information

    Device Name
    Sunrise
    K Number
    K250874
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2376
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sunrise SA
    Date Received
    March 24, 2025
    Decision Date
    August 29, 2025
    Product Code
    QRS
    Advisory Committee
    Ear, Nose, Throat
    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
    QRS Device For Sleep Apnea Testing Based On Mandibular Movement

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