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

    SOMNUM (V.1.1.2.)

    K Number: K223922 · Decision Aug 16, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    35
    Applicant Total
    1
    Review Days
    229

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    Basic Information

    Device Name
    SOMNUM (V.1.1.2.)
    K Number
    K223922
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Honeynaps Co., Ltd.
    Date Received
    December 30, 2022
    Decision Date
    August 16, 2023
    Product Code
    OLZ
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph

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