FDA issues new rules on pulse oximeter 510(k) submissions

03/8/2013 | MassDevice.com (Boston)

The FDA has released a document outlining its updated guidelines for submitting premarket notification applications for pulse oxymeters. The guidance document explains how manufacturers should identify, test or verify the safety of the devices when preparing their 510(k) submissions.

View Full Article in:

MassDevice.com (Boston)

Published in Briefs:

SmartBrief Job Listings for Health Care

Job Title Company Location
Counsel – Regulatory Affairs
RAI Services Company
Winston Salem, NC
Director of Program Development
AdvaMed
Washington DC, DC
Director of System QA
LifeWatch Services, Inc.
Rosemont, IL
Director of Business Development and Membership
AdvaMed
Washington DC, DC
Director, Corporate Counsel
Regeneron
Tarrytown, NY