The following data is part of a premarket notification filed by Ino Therapeutics with the FDA for Inomax Ds (delivery System).
Device ID | K121021 |
510k Number | K121021 |
Device Name: | INOMAX DS (DELIVERY SYSTEM) |
Classification | Apparatus, Nitric Oxide Delivery |
Applicant | INO THERAPEUTICS 2902 DAIRY DRIVE Madison, WI 53718 |
Contact | David Trueblood |
Correspondent | David Trueblood INO THERAPEUTICS 2902 DAIRY DRIVE Madison, WI 53718 |
Product Code | MRN |
Subsequent Product Code | MRP |
Subsequent Product Code | MRQ |
CFR Regulation Number | 868.5165 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-04-04 |
Decision Date | 2012-09-24 |
Summary: | summary |