The following data is part of a premarket notification filed by Ino Therapeutics Llc/dba Ikaria with the FDA for Inomax Ds(delivery Systems.
| Device ID | K113272 |
| 510k Number | K113272 |
| Device Name: | INOMAX DS(DELIVERY SYSTEMS |
| Classification | Apparatus, Nitric Oxide Delivery |
| Applicant | INO THERAPEUTICS LLC/DBA IKARIA 1060 Allendale Dr Port Allen, LA 70767 |
| Contact | Larry Lepley |
| Correspondent | Larry Lepley INO THERAPEUTICS LLC/DBA IKARIA 1060 Allendale Dr Port Allen, LA 70767 |
| Product Code | MRN |
| Subsequent Product Code | MPQ |
| Subsequent Product Code | MRP |
| CFR Regulation Number | 868.5165 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-04 |
| Decision Date | 2012-02-29 |
| Summary: | summary |