Clearance Summary
TI500 GLOBE-TROTTER TRANSPORT SYSTEM received FDA 510(k) clearance under submission number K001019, sponsored by Hill-Rom Air-Shields. 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 2000-04-27.
- Submission: K001019
- Applicant / Sponsor: Hill-Rom Air-Shields
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5410
- Decision date: 2000-04-27
Classification & Regulation
This clearance is catalogued under FDA product code FPL and 21 CFR 880.5410, within the General Hospital review panel as a Class II device.