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
Electric car maker Tesla's Chief Elon Musk confirmed that there will be no discount on new cars. Through several tweets and an email addressing its employees, Musk said, "It is absolutely vital that we adhere to the no negotiation and no discount policy that has been true since we first started taking orders 10 years ago." Shares of National Beverage Corp. fell about 15 percent on Wednesday after short selling firm Glaucus Research Group has said it is shorting the soft-drink maker and accused the company of manipulating earnings. In a research report, Glaucus alleged that National Beverage achieved its "remarkable history of financial performance in part by manipulating earnings." Canadian pipeline operator Enbridge Inc. said it has agreed to sell its liquids pipeline assets in the South Prairie Region, including the Saskatchewan pipeline system, to privately-held midstream company Tundra Energy Marketing Ltd. for C$1.075 billion in cash.
comments powered by Disqus
Follow RTT