NOxBOXi Nitric Oxide Delivery System— 510(k) K231823
Substantially EquivalentLinde Gas & Equipment, Inc.
FDA 510(k) clearance K231823 for NOxBOXi Nitric Oxide Delivery System, Substantially Equivalent on 2023-08-11. Applicant: Linde Gas & Equipment, Inc..
Clearance details
- Applicant
- Linde Gas & Equipment, Inc.
- Product code
- Code MRN
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Livingston, TN, US
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.