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

Issue Date: January 24, 2000
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, 510(k)
Status: Final

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

The purpose of this document is to facilitate the preparation and the review of premarket submissions for nitric oxide delivery apparatus, nitric oxide analyzers, and nitrogen dioxide analyzers.

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