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510(k) Data Aggregation

    K Number
    K240293
    Device Name
    STS
    Manufacturer
    TechboPulm, Ltd.
    Date Cleared
    2024-09-17

    (229 days)

    Product Code
    BZC
    Regulation Number
    868.1880
    Why did this record match?
    Applicant Name (Manufacturer) :

    TechboPulm, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The STS device is intended to measure lung function in adult patients while at rest (including spirometry and lung volumes). The STS device is to be used by either a physician, respiratory therapist, or technician. The STS device is intended to be used in a professional healthcare environment.
    Device Description
    The STS is a handheld spirometer intended to measure lung function in adult patients while at rest (including spirometry and lung volumes). The STS is to be used by either a physician, respiratory therapist, or technician. The STS device is pulmonary function testing device that measures both flow/volume (spirometry), lung volume and resistance/compliance parameters. It is a multi-use device that should be used with a compatible single-use, disposable mouthpiece which incorporates a viralbacterial filter protecting the patient from the internal components of the device is battery operated allowing for approximately 40 operating hours between charges. The measurement results, which are transmitted via Bluetooth, are displayed on the physician's computer via the STS software/App.
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