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510(k) Data Aggregation

    K Number
    K983619
    Device Name
    BARCHENS COMPANY DIGITAL PACIFIER THERMOMETER
    Manufacturer
    Date Cleared
    1998-11-02

    (18 days)

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

    BARCHENS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Barchens Digital Pacifier Thermometer is a non-sterile, re-usable clinical thermometer intended for the determination of oral body temperature in infants to children five years of age.
    Device Description
    The Barchens Digital Pacifier Thermometer, is a battery-powered, liquid crystal display device using a thermometer embedded in the nipple. The patient contact portion is composed of medical silicone rubber. The body is of ABS plastic . This device is reusable and no components are disposable. This device is not intended for use with other sheaths or devices.
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