Search Results

ZAN Lung-Function Lab is used to measure or monitor pulmonary function in adult and pediatric subjects during exercise (including diagnosis, training, and stress testing) or while at rest (including Spirometry, airway strength and output, diffusion capacity, body plethysmography, nutritional assessment, and indirect cardiac output) for diagnosis, training, assessment, and other related activities.

The ZAN Lung-Function Lab (LFL) is a full-featured, PC-based system for professional evaluation of pulmonary function, cardiopulmonary exercise capacity, and metabolism. A personal computer (PC) is the central component of the system, collecting data from pulmonary instruments, calculating lung-function test, stress, and training parameters, entering demographic and other subject information, and displaying/reporting the results. The system comprises Four pulmonary instruments (flow sensor with airway pressure capability, diffusion-gas analyzer, ventilation-gas analyzer, and body plethysmograph), a PC running a proprietary ZAN test program, test gases of known compositions, leads, tubes, and valves connecting the instruments and computer, and an optional cart for normalizing expansion. In addition, optional physiologic sensing equipment (including exercise electrocardiographs, pulse oximeters, etc.) may supply data to the LFL to provide expanded testing capability.

Here's a breakdown of the acceptance criteria and study information for the ZAN Lung-Function Lab, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary for the ZAN Lung-Function Lab primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant standards, rather than defining explicit acceptance criteria for specific performance metrics with target values to achieve. However, based on the text, we can infer some performance expectations and the reported compliance.

Ask a specific question about this device