510(k) K242374
K242374 is an FDA 510(k) premarket notification submitted by Airgas Therapeutics, LLC for the device "ULSPIRA TS Nitric Oxide Therapy System". The FDA issued a decision of Substantially Equivalent on January 17, 2025. The device falls under product code MRN (Apparatus, Nitric Oxide Delivery), a Class II device regulated under 21 CFR 868.5165. Airgas Therapeutics, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 17, 2025
- Date Received
- August 9, 2024
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Nitric Oxide Delivery
- Device Class
- Class II
- Regulation Number
- 868.5165
- Review Panel
- AN
- Submission Type