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

    Dream Sock

    K Number: DEN220091 · Decision Nov 8, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    329

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    Basic Information

    Device Name
    Dream Sock
    K Number
    DEN220091
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    870.2705
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Applicant
    Owlet Babycare, Inc.
    Date Received
    December 14, 2022
    Decision Date
    November 8, 2023
    Product Code
    QYU
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QYU Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use

    Similar 510(k) Clearances

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

    Masimo Stork

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
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    Other Clearances by Owlet Babycare, Inc.

    K Number Device Name
    K222597 BabySat 3