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

    Daylight

    K Number: K233872 · Decision Aug 30, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    2
    Review Days
    267

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    Basic Information

    Device Name
    Daylight
    K Number
    K233872
    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
    December 7, 2023
    Decision Date
    August 30, 2024
    Product Code
    SCP
    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
    SCP Computerized Behavioral Therapy Device For Anxiety Disorders

    Other Clearances by Big Health, Inc.

    K Number Device Name
    K233577 Sleepio®