21 CFR 868.5165 — Apparatus, Nitric Oxide Delivery
Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5165
Identification
The nitric oxide administration apparatus is a device used to add nitric oxide to gases that are to be breathed by a patient. The nitric oxide administration apparatus is to be used in conjunction with a ventilator or other breathing gas administration system.
Classification Rationale
Class II. The special control for this device is FDA's “Guidance Document for Premarket Notification Submissions for Nitric Oxide Administration Apparatus, Nitric Oxide Analyzer, and Nitrogen Dioxide Analyzer.”
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| MRN | Apparatus, Nitric Oxide Delivery | 2 | 33 | Life-Sustaining |
| MRO | Apparatus, Nitric Oxide, Backup Delivery | 2 | 4 | Life-Sustaining |
Special Controls
MRN — Apparatus, Nitric Oxide Delivery
The special control for this device is FDA's “Guidance Document for Premarket Notification Submissions for Nitric Oxide Administration Apparatus, Nitric Oxide Analyzer, and Nitrogen Dioxide Analyzer.”
Ecfr Llm
MRN — Apparatus, Nitric Oxide Delivery
The special control developed by the agency is a guidance document, entitled Guidance Document for Premarket Notification Submissions for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer. This guidance document identifies the risks associated with these types of devices and contains information that will help manufacturers address those risks. This document is available on FDA's website at http://www.fda.gov/cdrh/ode/1157.pdf.
De Novo Order DEN000001
