The following data is part of a premarket notification filed by Ino Therapeutics/ikaria with the FDA for Inomax Dsir Plus Mri.
| Device ID | K143213 |
| 510k Number | K143213 |
| Device Name: | INOmax DSIR Plus MRI |
| Classification | Apparatus, Nitric Oxide Delivery |
| Applicant | INO Therapeutics/Ikaria 6603 Femrite Drive Madison, WI 53718 |
| Contact | Robert Bovy |
| Correspondent | Robert Bovy INO Therapeutics/Ikaria 6603 Femrite Drive Madison, WI 53718 |
| Product Code | MRN |
| Subsequent Product Code | MRO |
| 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 | 2014-11-10 |
| Decision Date | 2015-07-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00867538000113 | K143213 | 000 |