The following data is part of a premarket notification filed by Ino Therapeutics Llc with the FDA for Inomax Ds (delivery System).
| Device ID | K090958 |
| 510k Number | K090958 |
| Device Name: | INOMAX DS (DELIVERY SYSTEM) |
| Classification | Ventilatory Effort Recorder |
| Applicant | INO THERAPEUTICS LLC 2902 DAIRY DR. Madison, WI 53718 |
| Contact | David Trueblood |
| Correspondent | David Trueblood INO THERAPEUTICS LLC 2902 DAIRY DR. Madison, WI 53718 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-06 |
| Decision Date | 2009-06-18 |
| Summary: | summary |