The following data is part of a premarket notification filed by Praxair, Inc. with the FDA for The Noxboxi Nitric Oxide Delivery System.
| Device ID | K201339 |
| 510k Number | K201339 |
| Device Name: | The NOxBOXi Nitric Oxide Delivery System |
| Classification | Apparatus, Nitric Oxide Delivery |
| Applicant | Praxair, Inc. 10 Riverview Drive Danbury, CT 06810 |
| Contact | Dave Loflin |
| Correspondent | Sarah Marie Fitzgerald Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746 |
| Product Code | MRN |
| Subsequent Product Code | CCL |
| Subsequent Product Code | MRO |
| 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 | 2020-05-20 |
| Decision Date | 2020-06-19 |