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

    NON-CONTACT THERMOMETER

    K Number: K120711 · Decision Nov 19, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    26
    Review Days
    256

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    NON-CONTACT THERMOMETER
    K Number
    K120711
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    K-Jump Health Co., Ltd.
    Date Received
    March 8, 2012
    Decision Date
    November 19, 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

    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)

    FDA 510(k)
    FDA Class 2 ·General Hospital

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

    FDA 510(k)
    FDA Class 2 ·General Hospital

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

    FDA 510(k)
    FDA Class 2 ·General Hospital

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

    FDA 510(k)
    FDA Class 2 ·General Hospital

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

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Infrared Thermometer

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by K-Jump Health Co., Ltd.

    K Number Device Name
    K180714 Probe Covers for Thermometers
    K170262 Digital Thermometer
    K141505 BASAL DIGITAL THERMOMETER
    K121520 ULTRASONIC NEBULIZER (MESH TYPE)
    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. →