(30 days)
The GEM is intended to be used for diagnostic use in the treatment of pulmonary illnesses with an intended use and indication for use as a configurable, non-invasive pulmonary function tester (PFT) testing system.. The GEM is indicated for use in: pulmonary function testing.
The Collins GEM (Gas Exchange Module) is a Pulmonary Function Test System. is intended as a configurable, non-invasive pulmonary function tester (PFT). These tests are suitable for both pediatric and adult patient testing. Compatible with the Collins' Body Plethysmograph as an optional module.
The GEM (Gas Exchange Module) is a configurable, non-invasive pulmonary function tester (PFT) testing system. It includes a spirometer (pneumotach), gas analyzers (infrared for CO, CO2, CH4 and electrochemical for O2), and associated electronics.
The Collins GEM (Gas Exchange Module) is a diagnostic spirometer intended for use in pulmonary function testing.
Here is a summary of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Parameter | Acceptance Criteria (Standard/Reference) | Reported Device Performance |
|---|---|---|
| Spirometer Metrics | ||
| Resistance (Pneumotach) |
§ 868.1840 Diagnostic spirometer.
(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).