510(k) DEN030001
DEN030001 is an FDA 510(k) premarket notification submitted by Aerocrine AB for the device "NIOX ARTICLE NO: 02-1000". The FDA issued a decision of De Novo Granted on April 30, 2003. The device falls under product code MXA (System, Test, Breath Nitric Oxide), a Class II device regulated under 21 CFR 862.3080. Aerocrine AB has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- April 30, 2003
- Date Received
- March 18, 2003
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Test, Breath Nitric Oxide
- Device Class
- Class II
- Regulation Number
- 862.3080
- Review Panel
- CH
- Submission Type