The following data is part of a premarket notification filed by Ino Therapeutics with the FDA for Inomax Dsir (delivery System).
| Device ID | K110344 |
| 510k Number | K110344 |
| Device Name: | INOMAX DSIR (DELIVERY SYSTEM) |
| 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 |
| CFR Regulation Number | 868.5165 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2011-02-04 |
| Decision Date | 2011-06-24 |
| Summary: | summary |