NIOX ARTICLE NO: 02-1000
Device Facts
| Record ID | DEN030001 |
|---|---|
| Device Name | NIOX ARTICLE NO: 02-1000 |
| Applicant | Aerocrine AB |
| Product Code | MXA · Clinical Toxicology |
| Decision Date | Apr 30, 2003 |
| Decision | DENG |
| Submission Type | Post-NSE |
| Regulation | 21 CFR 862.3080 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A breath nitric oxide test system is a device intended to measure fractional nitric oxide in human breath. Measurement of changes in fractional nitric oxide concentration in expired breath aids in evaluating an asthma patient's response to anti-inflammatory therapy, as an adjunct to established clinical and laboratory assessments of asthma. A breath nitric oxide test system combines chemiluminescence detection of nitric oxide with a pneumotachograph, display, and dedicated software.
Special Controls
*Classification.* Class II (special controls). The special control is FDA's guidance entitled “Class II Special Controls Guidance Document: Breath Nitric Oxide Test System.” See § 862.1(d) for the availability of this guidance document.
