510(k) K080484
K080484 is an FDA 510(k) premarket notification submitted by Ino Therapeutics for the device "INOMAX DS (DELIVERY SYSTEM), MODEL 10003". The FDA issued a decision of Substantially Equivalent on August 6, 2008. The device falls under product code MRN (Apparatus, Nitric Oxide Delivery), a Class II device regulated under 21 CFR 868.5165. Ino Therapeutics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 6, 2008
- Date Received
- February 22, 2008
- Clearance Type
- Special
- 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