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510(k) Data Aggregation

    K Number
    K112116
    Device Name
    DIGITAL CLINICAL THERMOMETER MODEL V901US
    Date Cleared
    2011-10-04

    (71 days)

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

    AMPEROR-ELECTRONIC(SZ) CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Digital Thermometer Model V901US is used for the intermittent measurement and monitoring of human body temperature, orally, rectally and under the arm. The device is intended for the adult and pediatric population. The Digital Thermometer Model V901US is a hand- held, non-sterile, reusable clinical thermometer intended for the determination of human temperature in either predictive ( Instant ) mode ( 10-seconds in oral, rectal mode and under the arm mode-predicative temperature, or standard mode (actual determination of temperature).
    Device Description
    The Digital Thermometer Model V901US is a hand- held, non-sterile, reusable clinical thermometer intended for the determination of human temperature in either predictive ( Instant ) mode ( 10-seconds in oral, rectal mode and under the arm mode-predicative temperature, or standard mode (actual determination of temperature).
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    K Number
    K082266
    Device Name
    DIGITAL CLINICAL THERMOMETER MODEL V9XX
    Date Cleared
    2008-11-07

    (88 days)

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

    AMPEROR-ELECTRONIC(SZ) CO., LTD

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