logo
Share SHARE
FONT-SIZE Plus   Neg

Covidien Nellcor Pulse Oximetry Portfolio Gets 510(k) Clearance For Motion Claim

Covidien (COV) announced that its Nellcor pulse oximetry portfolio, which is used to measure arterial oxygen saturation, has received FDA 510(k) clearance for motion claims. Covidien said it is the first company to receive FDA clearance for a motion-tolerant bedside pulse oximeter portfolio that is also compliant with ISO 80601-2-61.

The devices covered by the action: Nellcor Bedside SpO2 Patient Monitoring System; Bedside Respiratory Patient Monitoring System; and N-600x Pulse Oximetry Monitoring System are indicated for prescription-use only for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate. They are intended for neonatal, pediatric, and adult patients, and for well or poorly perfused patients in hospitals, hospital-type facilities, intra-hospital transport and home environments.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Everyone knows that the Federal Reserve will raise interest rates next Wednesday at the conclusion of its two-day policy meeting. After all, Fed speakers have been jawboning a rate hike over the past few weeks. With the markets reacting with eerie calm to Donald Trump's win, policy makers have no... GOP strategist Karl Rove has criticized U.S. President-elect Donald Trump's comments on aircraft maker Boeing Co.'s contract for a new Air Force One plane, saying they were inaccurate and de-stabled the stock of a major company. Air Force One is the official air plane for the U.S. President. Elon Musk's space transport company SpaceX has lost a satellite launch order from one of its customers due to the delay in its rocket launch schedule after one of its rockets exploded in September.
comments powered by Disqus
Follow RTT