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

    BI-TEMP TEMPERATURE MONITOR TM-201D

    K Number: K913083 · Decision Oct 17, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    518
    Registration Numbers
    518
    Same Product Code
    795
    Applicant Total
    27
    Review Days
    147

    Basic Information

    Device Name
    BI-TEMP TEMPERATURE MONITOR TM-201D
    K Number
    K913083
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    RESPIRATORY SUPPORT PRODUCTS, INC.
    Date Received
    May 23, 1991
    Decision Date
    October 17, 1991
    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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