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 |