The following data is part of a premarket notification filed by Mallinckrodt Manufacturing Llc with the FDA for Inomax Dsir Plus.
| Device ID | K200389 |
| 510k Number | K200389 |
| Device Name: | INOmax DSIR Plus |
| Classification | Apparatus, Nitric Oxide Delivery |
| Applicant | Mallinckrodt Manufacturing LLC 6603 Femrite Drive Madison, WI 53718 |
| Contact | David Trueblood |
| Correspondent | Jamie Yieh Mallinckrodt Hospital Products Inc. 1425 U.S. Route 206 Bedminster, NJ 07921 |
| Product Code | MRN |
| Subsequent Product Code | MRP |
| Subsequent Product Code | MRQ |
| CFR Regulation Number | 868.5165 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-18 |
| Decision Date | 2020-06-17 |