BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇧🇪 Belgium

    Sunrise Sleep Disorder Diagnostic Aid

    K Number: DEN210015 · Decision Jan 7, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    280

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    Basic Information

    Device Name
    Sunrise Sleep Disorder Diagnostic Aid
    K Number
    DEN210015
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    868.2376
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Unknown
    Applicant
    Sunrise
    Date Received
    April 2, 2021
    Decision Date
    January 7, 2022
    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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