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

    Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes

    K Number: K193338 · Decision Aug 25, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    14
    Review Days
    267

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    Basic Information

    Device Name
    Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes
    K Number
    K193338
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Med-Link Electronics Tech Co., Ltd.
    Date Received
    December 2, 2019
    Decision Date
    August 25, 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

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    Infrared Thermometer

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    Other Clearances by Shenzhen Med-Link Electronics Tech Co., Ltd.

    K Number Device Name
    K251160 Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)
    K220448 Disposable Non-invasive EEG Sensor
    K220447 Med-link Disposable ECG Cable and Leadwires
    K212752 Med-link Pulse Oximeter
    K210441 Incontinence Probe
    K202743 Med-Link Temp-pulse Oximeter
    K181154 Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor
    K182667 Med-link Temperature Probes
    K173869 Med-link Reusable Blood Pressure Cuff
    K160530 Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure Cuff
    Search all 14 clearances from Shenzhen Med-Link Electronics Tech Co., Ltd. →