510(k) K122689
K122689 is an FDA 510(k) premarket notification submitted by Ino Therapeutics for the device "INOBLENDER". The FDA issued a decision of Substantially Equivalent on November 7, 2012. The device falls under product code MRO (Apparatus, Nitric Oxide, Backup 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
- November 7, 2012
- Date Received
- September 4, 2012
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Nitric Oxide, Backup Delivery
- Device Class
- Class II
- Regulation Number
- 868.5165
- Review Panel
- AN
- Submission Type