BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Fever Scout

    K Number: K181013 · Decision Aug 21, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    3
    Review Days
    126

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    Basic Information

    Device Name
    Fever Scout
    K Number
    K181013
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    VivaLNK, Inc.
    Date Received
    April 17, 2018
    Decision Date
    August 21, 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 VivaLNK, Inc.

    K Number Device Name
    K191870 VV330 Continuous ECG Platform, VivaLNK Adhesive Patch
    K162137 Fever Scout™ Continuous Monitoring thermometer