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

    GENTLE EXPRESSIONS AUTOMATIC BREAST PUMP & FEED SY

    K Number: K852460 · Decision Nov 14, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    243
    Applicant Total
    8
    Review Days
    157

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    Basic Information

    Device Name
    GENTLE EXPRESSIONS AUTOMATIC BREAST PUMP & FEED SY
    K Number
    K852460
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5160
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Healthteam
    Date Received
    June 10, 1985
    Decision Date
    November 14, 1985
    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 Healthteam

    K Number Device Name
    K890586 INFRARED DELUXE
    K890585 INFRARED HEX
    K890588 GENTLE EXPRESSIONS ELECTRIC BREAST PUMP
    K852459 HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8175
    K852458 HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8145
    K852457 HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8165
    K852653 HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8115