Pulmonx Chartis Tablet Console

Primary DI

00811907031161

Brand

Pulmonx Chartis Tablet Console

Company

PULMONX CORPORATION

Model

CHR-CO-300

Device description

The Chartis Tablet Console is a two-part spirometry system comprised of a touchscreen computer and sensor enclosure designed for use in the bronchoscopy suite in conjunction with the Chartis Catheter. The Chartis Catheter is a previously cleared device (under K111522) and the subject 510(k) K180011 is solely for the Chartis Tablet Console. The proximal end of the Chartis Catheter is attached to a polymer tube with a filter whose opposite end is attached to an input fitting on the Chartis Console. Theballoon on the Chartis Catheter isolates the lung compartment of interest. The hardware components of the Tablet Console translate airflow and pressure detected through the Chartis Catheter into electrical signals. The Tablet Console analyzes and displays airflow and pressure from the isolated lung compartment in real time.

Published

2021-04-20

Public version status

Update

Distribution status

In Commercial Distribution

MRI safety

MR Unsafe

Rx

true