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

    FORA COMFORTSCAN EAR THERMOMETER

    K Number: K121118 · Decision Jun 15, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    5
    Review Days
    64

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    Basic Information

    Device Name
    FORA COMFORTSCAN EAR THERMOMETER
    K Number
    K121118
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Foracare, Inc.
    Date Received
    April 12, 2012
    Decision Date
    June 15, 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

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