BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    Fever Garde

    K Number: K191978 · Decision Dec 18, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    6
    Review Days
    513

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    Basic Information

    Device Name
    Fever Garde
    K Number
    K191978
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hubdic Co., Ltd.
    Date Received
    July 24, 2019
    Decision Date
    December 18, 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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    Other Clearances by Hubdic Co., Ltd.

    K Number Device Name
    K130361 THERMOFINDER; THERMOCARE
    K101912 THE INFRARED FOREHEAD THERMOMETER, MODEL FS-300&301
    K080636 DUO-MAX BLOOD PRESSURE & GLUCOSE MONITOR HMF-100
    K043331 DIGITAL FOREHEAD THERMOMETER, MODEL FS-100
    K023412 THERMO BUDDY, MODELS TB-100, TB-110, TB-120