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

    Tyto Stethoscope

    K Number: K160401 · Decision Oct 19, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    153
    Applicant Total
    10
    Review Days
    250

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    Basic Information

    Device Name
    Tyto Stethoscope
    K Number
    K160401
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1875
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tyto Care , Ltd.
    Date Received
    February 12, 2016
    Decision Date
    October 19, 2016
    Product Code
    DQD
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DQD Stethoscope, Electronic

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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
    K190242 Tyto Thermometer
    K181612 Tyto Stethoscope (OTC)