K242374
- 510(k) number
- K242374
- Device name
- ULSPIRA TS Nitric Oxide Therapy System
- Applicant
- Airgas Therapeutics, LLC PA · US
- Product code
- MRN — Apparatus, Nitric Oxide Delivery
- Decision date
- 2025-01-17
- Date received
- 2024-08-09
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K242374.pdf
Official FDA record: K242374
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.