The following data is part of a premarket notification filed by Ino Therapeutics Llc/dba Ikaria with the FDA for Inomax Ds(ir) (delivery System).
Device ID | K110635 |
510k Number | K110635 |
Device Name: | INOMAX DS(IR) (DELIVERY SYSTEM) |
Classification | Apparatus, Nitric Oxide Delivery |
Applicant | INO THERAPEUTICS LLC/DBA IKARIA 1060 Allendale Dr Port Allen, LA 70767 |
Contact | Larry Lepley |
Correspondent | Larry Lepley INO THERAPEUTICS LLC/DBA IKARIA 1060 Allendale Dr Port Allen, LA 70767 |
Product Code | MRN |
CFR Regulation Number | 868.5165 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2011-03-04 |
Decision Date | 2011-06-23 |
Summary: | summary |