Clearance Summary
ELITE 3 LOW AIR LOSS BED received FDA 510(k) clearance under submission number K945042, sponsored by Pegabus Egerton, Ltd.. 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 1995-03-16.
- Submission: K945042
- Applicant / Sponsor: Pegabus Egerton, Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5100
- Decision date: 1995-03-16
Classification & Regulation
This clearance is catalogued under FDA product code FNL and 21 CFR 880.5100, within the General Hospital review panel as a Class II device.