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

    Sunrise

    K Number: K222262 · Decision Dec 22, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    147

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Sunrise
    K Number
    K222262
    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
    July 28, 2022
    Decision Date
    December 22, 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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QRS), ordered by most recent decision date.

    Sunrise

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Sunrise Sleep Disorder Diagnostic Aid

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat
    View all

    Other Clearances by Sunrise SA

    K Number Device Name
    K250874 Sunrise