510(k) K143213
K143213 is an FDA 510(k) premarket notification submitted by Ino Therapeutics/Ikaria for the device "INOmax DSIR Plus MRI". The FDA issued a decision of Substantially Equivalent on July 10, 2015. The device falls under product code MRN (Apparatus, Nitric Oxide Delivery), a Class II device regulated under 21 CFR 868.5165. Ino Therapeutics/Ikaria has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 10, 2015
- Date Received
- November 10, 2014
- Clearance Type
- Traditional
- 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