Clearance Summary
HOVERJACK AIR PATIENT LIFT DEVICE received FDA 510(k) clearance under submission number K041503, sponsored by D.T. Davis Enterprises , 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 2004-08-12.
- Submission: K041503
- Applicant / Sponsor: D.T. Davis Enterprises , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5500
- Decision date: 2004-08-12
Classification & Regulation
This clearance is catalogued under FDA product code FNG and 21 CFR 880.5500, within the General Hospital review panel as a Class II device.