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510(k) Data Aggregation

    K Number
    K022542
    Device Name
    PHILIPS BABY THERMOMETER SET (SBC SC530)
    Date Cleared
    2002-08-20

    (19 days)

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

    PHILIPS CONSUMER ELECTRONICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Philips Baby Thermometer Set is intended for determination of a baby's oral, rectal, or axillary temperature. The set contains three items: A pacifier thermometer to detect baby's oral temperature. An ordinary pacifier can be used as a daily use pacifier to help accustom the baby to the shape of the pacifier-thermometer. A digital flexible-tip thermometer to detect baby's rectal or underarm (axillary) temperature.
    Device Description
    The Philips Baby Thermometer set allows parents to accurately and conveniently measure the baby's temperature. The baby thermometer set is designed for he baby's safety, comfort, well-being and, therefore, parents own peace of mind. The set contains three items: A soother thermometer to reliably measure baby's temperature. It is very convenient to use both for parents and baby. A digital flexible-tip thermometer that measures baby's body temperature rectally if parents want added reassurance.
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