BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    Tyto Thermometer

    K Number: K190242 · Decision Mar 27, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    10
    Review Days
    49

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    Basic Information

    Device Name
    Tyto Thermometer
    K Number
    K190242
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tyto Care , Ltd.
    Date Received
    February 6, 2019
    Decision Date
    March 27, 2019
    Product Code
    FLL
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    Y

    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 Tyto Care , Ltd.

    K Number Device Name
    K252844 Tyto Insights for Wheeze Detection (with PCCP)
    DEN250014 Tyto Insights for Eardrum Bulging Detection
    K252089 Tyto Stethoscope (G3)
    K243567 Tyto Insights for Rhonchi Detection
    K240555 Tyto Insights for Crackles Detection
    K232237 Tyto Insights for Wheeze Detection
    K221614 TytoCare Lung Sounds Analyzer
    K181612 Tyto Stethoscope (OTC)
    K160401 Tyto Stethoscope