The following data is part of a premarket notification filed by Ino Therapeutics with the FDA for Inoblender.
| Device ID | K122689 |
| 510k Number | K122689 |
| Device Name: | INOBLENDER |
| Classification | Apparatus, Nitric Oxide, Backup Delivery |
| Applicant | INO THERAPEUTICS 2902 DAIRY DRIVE Madison, WI 53718 |
| Contact | Robert Bovy |
| Correspondent | Robert Bovy INO THERAPEUTICS 2902 DAIRY DRIVE Madison, WI 53718 |
| Product Code | MRO |
| CFR Regulation Number | 868.5165 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-04 |
| Decision Date | 2012-11-07 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() INOBLENDER 79026694 3242739 Live/Registered |
AGA AB 2006-04-04 |