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

    Probe Covers for Thermometers

    K Number: K180714 · Decision Sep 24, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    26
    Review Days
    189

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    Basic Information

    Device Name
    Probe Covers for Thermometers
    K Number
    K180714
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    K-Jump Health Co., Ltd.
    Date Received
    March 19, 2018
    Decision Date
    September 24, 2018
    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 K-Jump Health Co., Ltd.

    K Number Device Name
    K170262 Digital Thermometer
    K141505 BASAL DIGITAL THERMOMETER
    K121520 ULTRASONIC NEBULIZER (MESH TYPE)
    K120711 NON-CONTACT THERMOMETER
    K103617 DIGITAL FOREHEAD THERMOMETER
    K102947 NON-CONTACT INFRARED THERMOMETER
    K092335 PEAK EXPIRATORY FLOW METER, KN-9710
    K092806 AUTO DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, MODEL KP-7770
    K083256 ULTRASONIC NEBULIZER SYSTEM, MODEL KN-9210
    K083753 SMART-LOGIC AUTO DIGITAL UPPERARM BLOOD PRESSURE MONITOR, MODEL KP-7500, FULLY FUZZY AUTO DIGITAL UPPER ARM BLOOD PRESSU
    Search all 26 clearances from K-Jump Health Co., Ltd. →