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510(k) Data Aggregation

    K Number
    K182437
    Device Name
    Wireless Intelligent Thermometer
    Date Cleared
    2019-05-05

    (240 days)

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

    Shenzhen Jumper Medical Equipment Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Thermometer is a non- invasive and re-usable electronic device for home use. The thermometer is intended for nonurgent ambulatory continuous left chest body temperature monitoring from ages 29 days and older.
    Device Description
    Wireless Intelligent Thermometer
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