BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    BELTER INFRA-RED EAR THERMOMETER

    K Number: K140681 · Decision Aug 21, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    3
    Review Days
    156

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    Basic Information

    Device Name
    BELTER INFRA-RED EAR THERMOMETER
    K Number
    K140681
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Belter Health Measurement and Analysis TE
    Date Received
    March 18, 2014
    Decision Date
    August 21, 2014
    Product Code
    FLL
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FLL Continuous Measurement Thermometer

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    Other Clearances by Shenzhen Belter Health Measurement and Analysis TE

    K Number Device Name
    K134029 BELTER BLOOD PRESSURE METER
    K122976 BODY FAT SCALE MODEL SF-371