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
Alaska Air Group Inc., which completed its $2.6 billion acquisition of Virgin America last year, said that the combined company will adopt Alaska Air's name and logo. The Virgin America name will be retired, "likely sometime in 2019," the airline added. Apple Inc. has agreed to acquire Workflow, an iOS app for automating tasks, as well as its development team for an undisclosed sum. Workflow is a personal automation tool that enables the user to drag and drop combination of actions to create workflows for the iPhone, iPad and Apple Watch. After long negotiations to win over one of the largest and fastest growing smart phone markets, Apple has decided to assemble its 4-inch screen iPhone SE in India.
comments powered by Disqus
Follow RTT