BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Sleepio®

    K Number: K233577 · Decision Aug 5, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    272

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    Basic Information

    Device Name
    Sleepio®
    K Number
    K233577
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5801
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Big Health, Inc.
    Date Received
    November 7, 2023
    Decision Date
    August 5, 2024
    Product Code
    QVO
    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
    QVO Computerized Behavioral Therapy Device For Insomnia

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