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

    TEMPTELLER INFARED EAR THERMOMETERS, MODEL CT-31/31DX/32/32DX

    K Number: K030299 · Decision Feb 25, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    6
    Review Days
    27

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    Basic Information

    Device Name
    TEMPTELLER INFARED EAR THERMOMETERS, MODEL CT-31/31DX/32/32DX
    K Number
    K030299
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Oriental System Technology, Inc.
    Date Received
    January 29, 2003
    Decision Date
    February 25, 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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    Other Clearances by Oriental System Technology, Inc.

    K Number Device Name
    K042202 TEMPTELLER - HIGH SPEED DIGITAL THERMOMETERS, MODELS DT-302, DT-312, DT-412, DT-502
    K010235 TEMPTELLER INFRARED EAR THERMOMETER, MODEL CT-30/ CT-30DX
    K001008 TEMPTELLER INFRARED EAR THERMOMETER, MODELS TT-901, TT-911 AND TT-921
    K992601 TEMP TELLER - DIGITAL THERMOMETER, MODELS DT-101, DT-102, DT-103, DT-201, DT-202, DT-203
    K984497 TEMP TELLER-INFRARED TYMPANIC THERMOMETER, MODELS TT-200, TT-201