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

    YUWELL Infrared Thermometer

    K Number: K201864 · Decision Dec 7, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    14
    Review Days
    154

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    Basic Information

    Device Name
    YUWELL Infrared Thermometer
    K Number
    K201864
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
    Date Received
    July 6, 2020
    Decision Date
    December 7, 2020
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FLL), ordered by most recent decision date.

    Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)

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    Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)

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    Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)

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    Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)

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    YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)

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    Infrared Thermometer

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    Other Clearances by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

    K Number Device Name
    K252779 YUWELL® Electronic Blood Pressure Monitor (YE630CR)
    K253228 YUWELL® Electronic Blood Pressure Monitor (YE650AR)
    K252805 YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)
    K242736 Portable Oxygen Concentrator (Spirit-3)
    K250878 YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)
    K213825 Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A
    K221372 YUWELL Electronic Blood Pressure Monitor
    K212385 YUWELL Finger Pulse Oximeter
    K203583 YUWELL infrared ear thermometer: YHT101, YHT200
    K200939 Electronic Blood Pressure Monitor
    Search all 14 clearances from Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. →