BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇬🇧 United Kingdom

    FETAL PILLOW

    K Number: DEN150053 · Decision Jul 27, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    617

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    Basic Information

    Device Name
    FETAL PILLOW
    K Number
    DEN150053
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    884.4350
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Unknown
    Applicant
    Safe Obstetric Systems, Ltd.
    Date Received
    November 18, 2015
    Decision Date
    July 27, 2017
    Product Code
    PWB
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PWB Fetal Head Elevator

    Similar 510(k) Clearances

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