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

    Disposable Ear Thermometer Probe Cover

    K Number: K203431 · Decision Jul 28, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    518
    Registration Numbers
    518
    Same Product Code
    795
    Applicant Total
    1
    Review Days
    247

    Basic Information

    Device Name
    Disposable Ear Thermometer Probe Cover
    K Number
    K203431
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Huaian Zhongxin Packing Material Co., Ltd.
    Date Received
    November 23, 2020
    Decision Date
    July 28, 2021
    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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