The following data is part of a premarket notification filed by Ino Therapeutics with the FDA for Inomax Ds.
| Device ID | K093922 |
| 510k Number | K093922 |
| Device Name: | INOMAX DS |
| Classification | Apparatus, Nitric Oxide Delivery |
| Applicant | INO THERAPEUTICS 2902 DAIRY DRIVE Madison, WI 53718 |
| Contact | Larry Lepley |
| Correspondent | Larry Lepley INO THERAPEUTICS 2902 DAIRY DRIVE Madison, WI 53718 |
| Product Code | MRN |
| Subsequent Product Code | MRO |
| Subsequent Product Code | MRP |
| Subsequent Product Code | MRQ |
| CFR Regulation Number | 868.5165 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-22 |
| Decision Date | 2010-04-15 |
| Summary: | summary |