BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OWLET BABY CARE

    Reg #: 3012977166 · FEI: 3012977166 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    2

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    Registration Details

    Registration Name
    OWLET BABY CARE
    Registration Number
    3012977166
    FEI Number
    3012977166
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2940 West Maple Loop Dr. Suite 203
    City
    Lehi
    State
    UT
    ZIP
    84048
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN220091

    Owner / Operator

    Firm Name
    Owlet Baby Care, Inc.
    Operator Number
    10084729
    Address
    2940 West Maple Loop Dr., Suite 203
    City
    Lehi
    State
    UT
    Postal Code
    84048
    Country
    US
    Correspondent
    Kristin Young

    Products

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

    Proprietary Names

    Dream Sock BabySat 3

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility