BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    tremoFlo C-100 Airwave Oscillometry System

    K Number: K170185 · Decision Sep 12, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    232

    Basic Information

    Device Name
    tremoFlo C-100 Airwave Oscillometry System
    K Number
    K170185
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1840
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    THORASYS Thoracic Medical Systems, Inc.
    Date Received
    January 23, 2017
    Decision Date
    September 12, 2017
    Product Code
    PNV
    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
    PNV Impedance Measuring Device Utilizing Oscillation Techniques

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