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

    CUDDLE UP PILLOW

    K Number: K882544 · Decision Jan 31, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    13
    Applicant Total
    19
    Review Days
    224

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    Basic Information

    Device Name
    CUDDLE UP PILLOW
    K Number
    K882544
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5680
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Ohio Medical Instrument Co., Inc.
    Date Received
    June 21, 1988
    Decision Date
    January 31, 1989
    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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