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

    NPAC DIGITAL THERMOMETER, MODELS ET 300, 301, 350, 351; ET 400, 401, 450, 451; ET 500, 501, 550, 551

    K Number: K031907 · Decision Aug 21, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    5
    Review Days
    62

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    Basic Information

    Device Name
    NPAC DIGITAL THERMOMETER, MODELS ET 300, 301, 350, 351; ET 400, 401, 450, 451; ET 500, 501, 550, 551
    K Number
    K031907
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Norm Pacific Automation Corp.
    Date Received
    June 20, 2003
    Decision Date
    August 21, 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 Norm Pacific Automation Corp.

    K Number Device Name
    K051835 NPAC MULTI-USE EAR THERMOMETER, MODELS TP 700,TP 702
    K030126 NPAC MULTI-USE EAR THERMOMETER, MODELS TD 600,610,620,630,602,612,622,632, TN 600,610,620,630,602,612,622,632, TS 600,6
    K011704 NPAC EAR THERMOMETER MODEL TD 402
    K010224 NPAC MULTI-USE THERMOMETER, MODEL TD400