510(k) K201339 ยท MRN Apparatus, Nitric Oxide Delivery
The NOxBOXi Nitric Oxide Delivery System
| Applicant | Praxair, Inc., Danbury CT, US |
| Decision | Substantially Equivalent, Jun 19, 2020 |
| Received | May 20, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K201339
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2026 | NOXBOX LTD NOxBOXi Nitric Oxide Delivery System. Model Number: NOXBOX-I. Open, Classified |
MRN | None listed |
| Sep 15, 2026 | NOXBOX LTD NOxBOXi Nitric Oxide Delivery System. Open, Classified |
MRN | None listed |
| Oct 6, 2025 | NOXBOX LTD NOxBOXi Nitric Oxide Delivery System;
Model Numbers: NOXBOX-I Open, Classified |
MRN | None listed |
| Oct 6, 2025 | NOXBOX LTD NOxBOXi Nitric Oxide Delivery System;
Model Numbers: NOXBOX-I Open, Classified |
MRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.