BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System

    K Number: K192210 · Decision Oct 10, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    7
    Review Days
    57

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    Basic Information

    Device Name
    ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System
    K Number
    K192210
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fiab Spa
    Date Received
    August 14, 2019
    Decision Date
    October 10, 2019
    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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    Infrared Thermometer

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    Other Clearances by Fiab Spa

    K Number Device Name
    K180047 ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System
    K123361 ESOTEST ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM
    K103783 EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRIC
    K100333 FIAB SPA, MODELS F7244, F7233, F7234, F7277
    K083428 F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTERY
    K091163 PG471W , PG471/50W, PG474W, PG477W, PG479/32W, PG479/50W, PG479/75W FIAB DISPOSABLE ELECTRODES WITH CABLE FOR ELECTRO-ST