PUG · Analyzer, Nitrogen Dioxide, Exempt
Anesthesiology · 21 CFR 868.2385 · Class 2
Overview
| Product Code | PUG |
|---|---|
| Device Name | Analyzer, Nitrogen Dioxide, Exempt |
| Regulation | 21 CFR 868.2385 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| Life-Sustaining | Yes |
Identification
The nitrogen dioxide analyzer is a device intended to measure the concentration of nitrogen dioxide in respiratory gas mixtures during administration of nitric oxide.
Classification Rationale
Class II (special controls). The device, when it is a standalone nitrogen dioxide analyzer and not those that are components of nitric oxide delivery systems intended to monitor nitrogen dioxide levels during inhaled nitric oxide therapy, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. The special control is FDA's “Guidance Document for Premarket Notification Submissions for Nitric Oxide Administration Apparatus, Nitric Oxide Analyzer, and Nitrogen Dioxide Analyzer.” See § 868.1(e) for the availability of this guidance document.
Special Controls
*Classification.* Class II (special controls). The device, when it is a standalone nitrogen dioxide analyzer and not those that are components of nitric oxide delivery systems intended to monitor nitrogen dioxide levels during inhaled nitric oxide therapy, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. The special control is FDA's “Guidance Document for Premarket Notification Submissions for Nitric Oxide Administration Apparatus, Nitric Oxide Analyzer, and Nitrogen Dioxide Analyzer.” See § 868.1(e) for the availability of this guidance document.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
