BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SONOSENTRY

    K Number: K131285 · Decision Aug 19, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    470

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    SONOSENTRY
    K Number
    K131285
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1900
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Isonea, Ltd.
    Date Received
    May 6, 2013
    Decision Date
    August 19, 2014
    Product Code
    PHZ
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PHZ Abnormal Breath Sound Device

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (PHZ), ordered by most recent decision date.

    Tyto Insights for Wheeze Detection (with PCCP)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Tyto Insights for Rhonchi Detection

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Tyto Insights for Crackles Detection

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Tyto Insights for Wheeze Detection

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TytoCare Lung Sounds Analyzer

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    wheezo WheezeRate Detector

    FDA 510(k)
    FDA Class 2 ·Anesthesiology
    View all