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
Diagnostic Technician
Roche
Marlborough, MA
Test Technician
Roche
Marlborough, MA
Compliance and Ethics Director
Sysmex America, Inc.
Lincolnshire, IL
Director, Site Quality Management
CareFusion
Palm Springs, CA
Compliance Officer-Medical Products
W. L. Gore
Flagstaff, AZ