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510(k) Data Aggregation

    K Number
    K101538
    Device Name
    HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP)
    Manufacturer
    PHILIPS ELECTRONICS UK LIMITED
    Date Cleared
    2010-11-05

    (155 days)

    Product Code
    HGY, HGW
    Regulation Number
    884.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHILIPS ELECTRONICS UK LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Philips Avent Manual Breast Pump is intended to express and collect milk from the breasts of a lactating woman.
    Device Description
    The Philips Avent Manual Breast Pump expresses and collects milk from the breast of a lactating woman. The device is designed to be reusable by a single user. The pump diaphragm is activated by a manual pivoting handle. The duckbill valve closes to prevent backflow and seal the device under negative pressure as the handle is depressed. The valve then relaxes to allow milk flow into the bottle between pump actuations. Pumping can only be performed on one breast at a time. The vacuum level can be adjusted to comfort by varying the speed and travel of the manual handle. The device is comprised of the manual breast pump parts and feeding bottle. The Philips Avent Manual Breast Pump operates in one mode - manual. In the manual mode, the user controls the frequency and level of vacuum by varying the stroke/cycle of the control handle lever. All milk-contacting and human tissue-contacting components are manufactured from materials that meet the appropriate regulations regarding food contact and/or biocompatibility.
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    K Number
    K100495
    Device Name
    PHILIPS AVENT DIGITAL THERMOMETER SET, MODEL SCH540
    Manufacturer
    PHILIPS ELECTRONICS UK LIMITED
    Date Cleared
    2010-06-22

    (123 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHILIPS ELECTRONICS UK LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Philips AVENT Digital Thermometer Set is intended for determination of temperature. The set contains three items: - A pacifier thermometer to detect baby's oral temperature. - . An ordinary pacifier that can be used as a daily used regular pacifier. - A digital flexible-tip thermometer that measures the oral, rectal, and axillary body temperature of humans.
    Device Description
    The Philips AVENT Digital Thermometer Set contains three items: - A pacifier thermometer to detect baby's oral temperature. - . An ordinary pacifier that can be used as a daily used regular pacifier. - A digital flexible-tip thermometer that measures the oral, rectal, and axillary body temperature of humans.
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    K Number
    K090167
    Device Name
    PHILIPS AVENT CLASSIC STAGE 2 AND 3 TEETHER, MODEL SCF882/01, SCF884/01, PHILIPS AVENT ANIMAL STAGE 2 AND 3 TEETHER,
    Manufacturer
    PHILIPS ELECTRONICS UK LIMITED
    Date Cleared
    2009-06-18

    (147 days)

    Product Code
    KKO
    Regulation Number
    872.5550
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHILIPS ELECTRONICS UK LIMITED

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