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

    VIVATHERM THEMPERATURE MEASUREMENT SYSTEM

    K Number: K031556 · Decision Jun 23, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    10
    Review Days
    35

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    Basic Information

    Device Name
    VIVATHERM THEMPERATURE MEASUREMENT SYSTEM
    K Number
    K031556
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vivant Medical, Inc.
    Date Received
    May 19, 2003
    Decision Date
    June 23, 2003
    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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