510(k) DEN000001
DEN000001 is an FDA 510(k) premarket notification submitted by Ohmeda Medical for the device "OHMEDA INOVENT DELIVERY SYSTEM". The FDA issued a decision of De Novo Granted on January 11, 2000. The device falls under product code MRN (Apparatus, Nitric Oxide Delivery), a Class II device regulated under 21 CFR 868.5165. Ohmeda Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- January 11, 2000
- Date Received
- January 7, 2000
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Nitric Oxide Delivery
- Device Class
- Class II
- Regulation Number
- 868.5165
- Review Panel
- AN
- Submission Type