510(K) clearance for Mallinckrodt's new spirometer:
This article was originally published in Clinica
Executive Summary
Mallinckrodt has received FDA 510(k) clearance to market its new device which can be used to measure lung capacity and performance in a doctor's office. Known as the Simplicity Spirometer, the inexpensive device was designed to support the new US National Lung Health Education Program for the early detection and prevention of chronic obstructive pulmonary disease (COPD). According to the US company, COPD, which includes emphysema and chronic bronchitis, causes 105,000 deaths each year in the US.