510(k) K110635
K110635 is an FDA 510(k) premarket notification submitted by Ino Therapeutics, LLC/Dba Ikaria for the device "INOMAX DS(IR) (DELIVERY SYSTEM)". The FDA issued a decision of Substantially Equivalent on June 23, 2011. The device falls under product code MRN (Apparatus, Nitric Oxide Delivery), a Class II device regulated under 21 CFR 868.5165. Ino Therapeutics, LLC/Dba Ikaria has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 23, 2011
- Date Received
- March 4, 2011
- 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