The NOxBOXi Nitric Oxide Delivery System— 510(k) K201339
Substantially EquivalentPraxair, Inc.
FDA 510(k) clearance K201339 for The NOxBOXi Nitric Oxide Delivery System, Substantially Equivalent on 2020-06-19. Applicant: Praxair, Inc.. Device class: 2.
Clearance details
- Applicant
- Praxair, Inc.
- Product code
- Code MRN
- Device class
- Class 2
- Regulation
- 21 CFR 868.5165
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Danbury, CT, US
Recent devices under product code MRN
view allMore clearances from Praxair, Inc.
view allAdverse events under product code MRN
product code MRN- Death
- 9
- Malfunction
- 910
- Total
- 919
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K201339
K-number listed on FDA's recall record- Z-0028-2026 — NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
- Z-0029-2026 — NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K201339.
Data sourced from openFDA. This site is unofficial and independent of the FDA.