21 CFR 868.2380 — Analyzer, Nitric Oxide
Anesthesiology (AN) · Part 868 Subpart C—Monitoring Devices · § 868.2380
Identification
The nitric oxide analyzer is a device intended to measure the concentration of nitric oxide in respiratory gas mixtures during administration of nitric oxide.
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 |
|---|---|---|---|---|
| MRP | Analyzer, Nitric Oxide | 2 | 1 |
Special Controls
MRP — Analyzer, Nitric Oxide
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.”
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