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

    SIMPLICITY TM ELECTRIC/BATTERY BREAST PUMP KIT (1068)

    K Number: K964403 · Decision Jan 13, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    243
    Applicant Total
    4
    Review Days
    70

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    Basic Information

    Device Name
    SIMPLICITY TM ELECTRIC/BATTERY BREAST PUMP KIT (1068)
    K Number
    K964403
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5160
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    The First Years, Inc.
    Date Received
    November 4, 1996
    Decision Date
    January 13, 1997
    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 The First Years, Inc.

    K Number Device Name
    K032845 EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 1187
    K033131 NATURAL COMFORT DOUBLE ELECTRIC/BATTERY BREAST PUMP, MODEL 1181/1068
    K032566 NATURAL COMFORT BATTERY/ELECTRIC BREAST PUMP