BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇰🇷 South Korea

    Sleep Apnea Feature

    K Number: DEN230041 · Decision Feb 6, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    40
    Review Days
    251

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    Basic Information

    Device Name
    Sleep Apnea Feature
    K Number
    DEN230041
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    868.2378
    Medical Specialty
    Anesthesiology
    Decision
    Unknown
    Applicant
    Samsung Electronics Co., Ltd.
    Date Received
    May 31, 2023
    Decision Date
    February 6, 2024
    Product Code
    QZW
    Advisory Committee
    Anesthesiology
    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
    QZW Over-The-Counter Device To Assess Risk Of Sleep Apnea

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