MRP · Analyzer, Nitric Oxide
Anesthesiology · 21 CFR 868.2380 · Class 2
Overview
| Product Code | MRP |
|---|---|
| Device Name | Analyzer, Nitric Oxide |
| Regulation | 21 CFR 868.2380 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
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.”
Special Controls
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.”
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K023014 | VIANOX DELIVERY SYSTEM, MODEL I | Pulmonox Medical, Inc. | Aug 14, 2003 | SESE |
Top Applicants
- Pulmonox Medical, Inc. — 1 clearance
