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510(k) Data Aggregation

    K Number
    K223625
    Device Name
    CapnoSpot™ Pneumothorax Decompression Indicator
    Manufacturer
    Pneumeric, Inc.
    Date Cleared
    2023-03-28

    (113 days)

    Product Code
    GAA
    Regulation Number
    878.4800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Pneumeric, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Used for more accurate placement of pneumothorax decompression devices than the current standard of care auditory assessments. The Pneumothorax Decompression Indicator is a colorimetric capnography device indicated to detect the carbon dioxide in the gas passing through the device used to treat pneumothorax with suspected tension physiology.
    Device Description
    The Pneumeric Capnospot Pneumothorax Decompression Indicator is a capnography device that provides objective, real-time feedback during decompressive thoracostomy. Specifically, the device detects the presence of carbon dioxide in the gas from the decompressed pneumothorax, permitting more accurate placement of the needle or thoracostomy device compared to the current standard of care based upon auditory assessments. The Pneumeric Capnospot is a therapeutic device intended to guide the placement of pneumothorax decompression needles and thoracostomy devices. The product consists of a cylindrical polycarbonate tube containing a carbon dioxide detecting paper. The device has a male luer connector on the distal end of the device to connect to decompression needles and thoracostomy devices, a diaphragm to prevent backflow of gases, a color changing indicator and a female luer on the proximal end of the device that can be used to connect accessories. The product is shipped non-sterile and labeled for single use only.
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