510(k) K071516
K071516 is an FDA 510(k) premarket notification submitted by Ino Therapeutics, LLC for the device "INOMAX DS". The FDA issued a decision of Substantially Equivalent on October 3, 2007. The device falls under product code MRN (Apparatus, Nitric Oxide Delivery), a Class II device regulated under 21 CFR 868.5165. Ino Therapeutics, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 3, 2007
- Date Received
- June 4, 2007
- 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