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
MGR POST MARKET STUDIES - 14000001LK
Abbott
Santa Ana, CA
Regulatory Analyst
Delta Dental
Alpharetta, GA
Associate Director, Regulatory Affairs - Promotional Review
Novo Nordisk
Princeton, NJ
Eastern Zone Sales Director
Regenesis Biomedical
Multiple Locations, SL_Multiple Locations
Senior Financial Analyst - Growing Manager Care Health Org
Fallon Community Health Plan
Worcester, MA