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510(k) Data Aggregation

    K Number
    K112289
    Device Name
    DISPOSABLE THERMOMETER COVERS AND SHEATHS
    Manufacturer
    KANG ZE INDUSTRIAL CO. LIMITED
    Date Cleared
    2011-12-16

    (129 days)

    Product Code
    FLL
    Regulation Number
    880.2910
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    Matched: '880.2920'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Thermometer Covers and Sheaths are intended for use as barriers between digital or mercury thermometers and users' rectum or oral cavities to avoid the possible contamination and infection during temperature measuring. These covers and sheaths are non-sterile and intended for single use only.
    Device Description
    The Disposable Thermometer Covers and Sheaths, made of PE and EVA, are used for either oral or rectal measurements for digital or mercury thermometers. The products and packaging are non-sterile and are not made with natural rubber latex. The size may vary to accommodate differences in digital and mercury thermometers. The inner packing material is paper, while the outer packing material is carton. Each outer packing contains 100 pieces of covers and sheaths.
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    K Number
    K983582
    Device Name
    CARDIOBEEPER CB250
    Manufacturer
    MERDIAN MEDICAL TECHNOLOGIES LTD.
    Date Cleared
    1998-11-13

    (31 days)

    Product Code
    DXH
    Regulation Number
    870.2920
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    Matched: '880.2920'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THE CARDIOBEEPER CB250 IS INDICATED FOR USE BY THE PATIENT IN TRANSMITTING ECG INFORMATION FROM A REMOTE LOCATION To A RECEIVING CENTER.
    Device Description
    The CardioBeeper ® CB250 is a single-lead, compact, hand-held, battery powered, personal transtelephonic ECG transmitter enclosed in a billfold wallet. The device has been designed to enable the user to transmit a rhythm strip to a central receiving station using acoustic coupling. The ECG information is transmitted as a frequency modulation of the basic 1700Hz tone. The device is sealed (not hermetically) for life. There are no user-servicable parts inside. The batteries are not replaceable and the unit should be discarded after depletion.
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