Clearance Summary
NIOX ARTICLE NO: 02-1000 received FDA 510(k) clearance under submission number DEN030001, sponsored by Aerocrine AB. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Clinical Toxicology review panel. The statutory decision date of record is 2003-04-30.
- Submission: DEN030001
- Applicant / Sponsor: Aerocrine AB
- Clearance pathway: Post-NSE
- Review panel: Clinical Toxicology
- Device class: Class II
- Regulation citation: 21 CFR 862.3080
- Decision date: 2003-04-30
Classification & Regulation
This clearance is catalogued under FDA product code MXA and 21 CFR 862.3080, within the Clinical Toxicology review panel as a Class II device.