Ulspira TS Nitric Oxide Therapy System— 510(k) K212409
Substantially EquivalentAirgas Therapeutics
FDA 510(k) clearance K212409 for Ulspira TS Nitric Oxide Therapy System, Substantially Equivalent on 2023-06-30. Applicant: Airgas Therapeutics.
Clearance details
- Applicant
- Airgas Therapeutics
- Product code
- Code MRN
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Houston, TX, 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.