Guidance Document for Premarket Notification Submissions for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer: Guidance for Industry and for FDA Reviewers
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
January 24, 2000
February 28, 2020
2a219aad-8a12-4304-ae5a-e38064f0898b
Related Documents
Guidance on Section 216 of the Food and Drug Administration Modernization Act of 1997 - Guidance for Industry and for FDA Reviewers
Guidance DocumentAugust 8, 2000Center for Devices and Radiological Health
Premarket Notification [510(k)] Submissions for Chemical Indicators - Guidance for Industry and FDA Staff
Guidance DocumentDecember 18, 2003Center for Devices and Radiological Health
Determination of Intended Use for 510(k) Devices - Guidance for CDRH Staff (Update to K98-1)
Guidance DocumentDecember 2, 2002Center for Devices and Radiological Health
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust GKS for their regulatory compliance needs.
Try KeyPedia Today
Explore our real use cases and discover our features in depth.
Subscribe to our newsletter
Get the latest updates and insights delivered to your inbox