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

    MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1

    K Number: K020725 · Decision Mar 12, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    518
    Registration Numbers
    518
    Same Product Code
    795
    Applicant Total
    13
    Review Days
    6

    Basic Information

    Device Name
    MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1
    K Number
    K020725
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    MICROLIFE CORP.
    Date Received
    March 6, 2002
    Decision Date
    March 12, 2002
    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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