BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PJ'S SERENITY

    K Number: K132220 · Decision Feb 20, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    243
    Applicant Total
    4
    Review Days
    583

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    Basic Information

    Device Name
    PJ'S SERENITY
    K Number
    K132220
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5160
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Limerick, Inc.
    Date Received
    July 17, 2013
    Decision Date
    February 20, 2015
    Product Code
    HGX
    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
    HGX Pump, Breast, Powered

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    Other Clearances by Limerick, Inc.

    K Number Device Name
    K051926 LIMERICK PJ'S COMFORT JR PORTABLE ELECTRIC BREAST PUMP
    K021739 LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002
    K012275 PJ.S COMFORT PORTABLE ELECTRIC BREAST PUMP