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510(k) Data Aggregation

    K Number
    K983776
    Device Name
    EVENFLO COMFORT CONTROL BREAST PUMP, EVENFLO COMFORT CONTROL DUAL BREAST PUMP
    Manufacturer
    EVENFLO CO., INC.
    Date Cleared
    1999-04-26

    (182 days)

    Product Code
    HGX
    Regulation Number
    884.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    EVENFLO CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Evenflo Comfort Control Breast Pump and Comfort Control Dual Breast Pump are personal use battery/electric powered suction devices used to express milk from the breast of lactating women. These devices are not intended for hospital use.
    Device Description
    The Evenflo Comfort Control Adjustable Speed Breast Pump with Automatic Cycling, and the Evenflo Comfort Control Dual Adjustable Speed Breast Pump with Automatic Cycling are diaphragm type pumps, driven by small DC motors, that create cycling negative pressure. The negative pressure generated by the pump is sufficient to overcome the resistance to the outflow of milk that is created by the muscles, yet gentle enough to prevent tissue damage to the user. The cycling speed and the strength of the negative pressure are controlled by individual rotary controls located on the pump unit. The combination of cycling speed and negative pressure control allow for a range of pressures to be selected. When used as a single collection pump, the maximum negative pressure ranges from 173 mm Hg to 56 mm Hg, and when used in the dual mode, it ranges from 173 mm Hg to 43 mm Hg.
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    K Number
    K960727
    Device Name
    EVENFLO NATURAL MOTHER ELECTRIC BREAST PUMP KIT
    Manufacturer
    EVENFLO CO., INC.
    Date Cleared
    1997-02-14

    (358 days)

    Product Code
    HGX
    Regulation Number
    884.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    EVENFLO CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K960726
    Device Name
    EVENFLO SOFT-TOUCH ULTRA BATTERY OPERATED BREAST PUMP
    Manufacturer
    EVENFLO CO., INC.
    Date Cleared
    1996-07-22

    (151 days)

    Product Code
    HGX
    Regulation Number
    884.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    EVENFLO CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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