The following data is part of a premarket notification filed by Ino Therapeutics Llc with the FDA for Inomax Ds (delivery System), Model 10003.
| Device ID | K092545 |
| 510k Number | K092545 |
| Device Name: | INOMAX DS (DELIVERY SYSTEM), MODEL 10003 |
| Classification | Apparatus, Nitric Oxide Delivery |
| Applicant | INO THERAPEUTICS LLC 2902 DAIRY DR. Madison, WI 53718 |
| Contact | Larry Lepley |
| Correspondent | Larry Lepley INO THERAPEUTICS LLC 2902 DAIRY DR. 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 | Yes |
| Date Received | 2009-08-19 |
| Decision Date | 2010-03-10 |
| Summary: | summary |