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    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Temperature Probe

    K Number: K173194 · Decision Oct 10, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    5
    Review Days
    373

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    Basic Information

    Device Name
    Temperature Probe
    K Number
    K173194
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Orantech, Inc.
    Date Received
    October 2, 2017
    Decision Date
    October 10, 2018
    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

    Similar 510(k) Clearances

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    Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)

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    Infrared Thermometer

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    Other Clearances by Orantech, Inc.

    K Number Device Name
    K182327 Patient Cables and Leadwires , Disposable ECG Leadwires
    K181270 Disposable SpO2 Sensors, Reusable SpO2 Sensors
    K173197 Reusable NIBP Cuff
    K171828 ETCO2 Sensor