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

    INFRARED THERMOMETER

    K Number: K113761 · Decision Sep 7, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    6
    Review Days
    261

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    Basic Information

    Device Name
    INFRARED THERMOMETER
    K Number
    K113761
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Famidoc Technology Co., Ltd.
    Date Received
    December 21, 2011
    Decision Date
    September 7, 2012
    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 Famidoc Technology Co., Ltd.

    K Number Device Name
    K212918 Heat StimPlus
    K130723 FDES106 MINI TENS&EMS DEVICE,FDES106 MULTI-FUNCTION MINI TENS&EMS DEVICE,FDES105 PAIN RELIEF PLASTER,FDES107 ABDOMINAL
    K113010 FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR
    K072641 DIGITAL ELECTRONIC THERMOMETER, MODEL: FDTH-V0-1 THRU 4.
    K052849 INFRARED THERMOMETER, FDIR-V1