ULSPIRA TS Nitric Oxide Therapy System— 510(k) K242374

Substantially Equivalent

Airgas Therapeutics, LLC

FDA 510(k) clearance K242374 for ULSPIRA TS Nitric Oxide Therapy System, Substantially Equivalent on 2025-01-17. Applicant: Airgas Therapeutics, LLC.

Clearance details

Applicant: Airgas Therapeutics, LLC
Product code: Code MRN
Advisory panel: Anesthesiology
Date received: 2024-08-09
Decision date: 2025-01-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Plumsteadville, PA, 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.