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

    INFRARED EAR THERMOMETER, ET-100 SERIES

    K Number: K041692 · Decision Sep 13, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    7
    Review Days
    83

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    Basic Information

    Device Name
    INFRARED EAR THERMOMETER, ET-100 SERIES
    K Number
    K041692
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Hangzhou Hua'An Medical & Health Instruments Co.,
    Date Received
    June 22, 2004
    Decision Date
    September 13, 2004
    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 Hangzhou Hua'An Medical & Health Instruments Co.,

    K Number Device Name
    K122912 DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER)
    K092447 DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER), DT SERIES
    K092514 UPPERARM DIGITAL BLOOD PRESSURE MONITOR, MODEL: MB-300 SERIES
    K041693 WRIST DIGITAL BLOOD PRESSURE MONITOR (DIGITAL SPHYGMOMANOMETER), MW-300 SERIES
    K041694 DIGITAL FLEXIBLE THERMOMETER, BASIC DIGITAL THERMOMETER, DITITAL PACIFIER THERMOMETER
    K030361 JASUN, MODELS DT-01F AND DT-11F