The following data is part of a premarket notification filed by Praxair Distribution, Inc with the FDA for Noxboxi Nitric Oxide Delivery System.
| Device ID | K171696 |
| 510k Number | K171696 |
| Device Name: | NOxBOXi Nitric Oxide Delivery System |
| Classification | Apparatus, Nitric Oxide Delivery |
| Applicant | Praxair Distribution, Inc 10 Riverview Drive Danbury, CT 06810 |
| Contact | Michael E. Skrjanc |
| Correspondent | Michael E. Skrjanc Praxair Distribution, Inc 10 Riverview Drive Danbury, CT 06810 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-07 |
| Decision Date | 2018-10-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060541640191 | K171696 | 000 |
| 95060541640125 | K171696 | 000 |
| 95060541640132 | K171696 | 000 |
| 95060541640149 | K171696 | 000 |
| 15060541640167 | K171696 | 000 |
| 05060541640016 | K171696 | 000 |
| 05060541640023 | K171696 | 000 |
| 25060541640034 | K171696 | 000 |
| 25060541640041 | K171696 | 000 |
| 25060541640058 | K171696 | 000 |
| 25060541640065 | K171696 | 000 |
| 25060541640072 | K171696 | 000 |
| 25060541640089 | K171696 | 000 |
| 05060541640184 | K171696 | 000 |
| 95060541640118 | K171696 | 000 |