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

    tremoflo C2 Airwave Oscillometry System

    K Number: K221024 · Decision Jun 20, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    440

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    Basic Information

    Device Name
    tremoflo C2 Airwave Oscillometry System
    K Number
    K221024
    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
    April 6, 2022
    Decision Date
    June 20, 2023
    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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    Other Clearances by Thorasys Thoracic Medical Systems, Inc.

    K Number Device Name
    K170185 tremoFlo C-100 Airwave Oscillometry System