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

    PREMIE COMFORT PAD PATIENT & INFANT SUPPORT PADS

    K Number: K844176 · Decision Jan 23, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    13
    Applicant Total
    1
    Review Days
    90

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    Basic Information

    Device Name
    PREMIE COMFORT PAD PATIENT & INFANT SUPPORT PADS
    K Number
    K844176
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5680
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Premie Comfort Products
    Date Received
    October 25, 1984
    Decision Date
    January 23, 1985
    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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