Clearance Summary
AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM; MODELS- SYS 1000, L3 WITH N100 ARM, 4B SOFTWARE received FDA 510(k) clearance under submission number K013562, sponsored by Baxter Healthcare Corp. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2002-12-12.
- Submission: K013562
- Applicant / Sponsor: Baxter Healthcare Corp
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5860
- Decision date: 2002-12-12
Classification & Regulation
This clearance is catalogued under FDA product code KDI and 21 CFR 876.5860, within the Gastroenterology, Urology review panel as a Class II device.