NOxBOXi Nitric Oxide Delivery System— 510(k) K233251

Substantially Equivalent

Linde Gas & Equipment, Inc.

FDA 510(k) clearance K233251 for NOxBOXi Nitric Oxide Delivery System, Substantially Equivalent on 2024-05-23. Applicant: Linde Gas & Equipment, Inc..

Clearance details

Applicant: Linde Gas & Equipment, Inc.
Product code: Code MRN
Advisory panel: Anesthesiology
Date received: 2023-09-28
Decision date: 2024-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Livingston, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MRN

product code MRN

Death: 9
Malfunction: 910
Total: 919

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.