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
Toy maker Hasbro Inc. (HAS) reported a profit for the fourth-quarter 2015 that grew about 3.5% from last year. Quarterly net revenues increased 13% from the prior year. Both earnings per share and revenue for the quarter beat analysts' expectations. Healthcare plan provider Centene Corp. (CNC) has been executing on its strategic objectives, including margin expansion. With its growing portfolio of integrated health solutions, Centene has a strong presence in government-sponsored healthcare, the highest growth category in the industry. A California man has filed a lawsuit against McDonald's alleging that the fast food giant is defrauding customers by cramming its mozzarella sticks with filler instead of real cheese. Chris Howe is seeking at least $5 million in damages on behalf of consumers in 42 states and the District of Columbia. The...
comments powered by Disqus
Follow RTT