Clearance Summary
DYNAMIC GERMICIDAL AIR PURIFICATION SYSTEM received FDA 510(k) clearance under submission number K933454, sponsored by L&H Airco. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1994-09-16.
- Submission: K933454
- Applicant / Sponsor: L&H Airco
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6500
- Decision date: 1994-09-16
Classification & Regulation
This clearance is catalogued under FDA product code FRA and 21 CFR 880.6500, within the General Hospital review panel as a Class II device.