Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Medical Devices
Topics
Pediatric Product Development, Premarket
Published
March 3, 2013
Last updated
April 11, 2024
Description
A guidance document for the premarket notification submissions of pulse oximeters by the FDA and industry staff.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)