AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM; MODELS- SYS 1000, L3 WITH N100 ARM, 4B SOFTWARE

AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM; MODELS- SYS 1000, L3 WITH N100 ARM, 4B SOFTWARE is an FDA 510(k)-cleared medical device (K013562) manufactured by Baxter Healthcare Corp. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 11, 2002. Regulation: 8.