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510(k) Data Aggregation

    K Number
    K103407
    Device Name
    COTRONIC DIGITAL THERMOMETER
    Date Cleared
    2011-05-13

    (175 days)

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

    COTRONIC MANUFACTURING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This clinical electronic thermometer is used over the counter to measure the human body temperature orally, auxiliary, and through the rectum.
    Device Description
    The clinical electronic thermometer is used over the counter to measure the human body temperature orally, auxiliary, and through the rectum. The device has the following skin contact parts: stainless steel tip, ABS plastic housing, and Ethylene/Butylene-Styrene Block thermoplastic housing. The method used to measure the temperature of a human follows the standard ASTM E1112(Standard Specifications for Electronic Thermometer for Intermittent Determination of Patient Temperature).
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    K Number
    K032434
    Device Name
    CLINICAL ELECTRONIC THERMOMETER
    Date Cleared
    2004-12-27

    (509 days)

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

    COTRONIC MANUFACTURING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device measures the human body temperature from oral, armpit, and rectal. The device is reuseable and intended for clinical or home use on people of all ages.
    Device Description
    The Clinical Electronic Thermometer is a thermometer intended for the determination of oral, axillary, and rectal body temperature determination in humans.
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