NOxBOXi Nitric Oxide Delivery System— 510(k) K171696

Substantially Equivalent

Praxair Distribution, Inc.

FDA 510(k) clearance K171696 for NOxBOXi Nitric Oxide Delivery System, Substantially Equivalent on 2018-10-02. Applicant: Praxair Distribution, Inc..

Clearance details

Applicant: Praxair Distribution, Inc.
Product code: Code MRN
Advisory panel: Anesthesiology
Date received: 2017-06-07
Decision date: 2018-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danbury, CT, 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.