BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    INFANT SLEEP BEANIE

    K Number: K082367 · Decision Jun 12, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    13
    Applicant Total
    1
    Review Days
    298

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    Basic Information

    Device Name
    INFANT SLEEP BEANIE
    K Number
    K082367
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5680
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Life Innovations, LLC
    Date Received
    August 18, 2008
    Decision Date
    June 12, 2009
    Product Code
    FRP
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FRP Holder, Infant Position

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