Clearance Summary
AIRPURGE received FDA 510(k) clearance under submission number DEN080009, sponsored by Anesthesia Safety Products, LLC. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2014-03-04.
- Submission: DEN080009
- Applicant / Sponsor: Anesthesia Safety Products, LLC
- Clearance pathway: Post-NSE
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5445
- Decision date: 2014-03-04
Classification & Regulation
This clearance is catalogued under FDA product code OKL and 21 CFR 880.5445, within the General Hospital review panel as a Class II device.