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    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    INFRARED EAR THERMOMETER, MODEL IR-04MT

    K Number: K102934 · Decision Jan 14, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    6
    Review Days
    102

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    Basic Information

    Device Name
    INFRARED EAR THERMOMETER, MODEL IR-04MT
    K Number
    K102934
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vega Technologies, Inc.
    Date Received
    October 4, 2010
    Decision Date
    January 14, 2011
    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 Vega Technologies, Inc.

    K Number Device Name
    K102625 VEGA CPAP SYSTEM/HEATED HUMIDIFIER, MODEL CP-03
    K102626 VEGA MEDICAL SUCTION EQUIPMENT, MODEL SU-01/SU-DC01
    K041516 DIGITAL THERMOMETER, MODELS MT-XX8 AND MT-XX9
    K031413 VIGORMIST COMPRESSOR NEBULIZER
    K002831 VEGA ULTRASONIC NEBULIZER