BCI 1621 OXIMETRY DATA MANAGEMENT PROGRAM

BCI 1621 OXIMETRY DATA MANAGEMENT PROGRAM is an FDA 510(k)-cleared medical device (K013862) manufactured by Bci, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 20, 2002. Regulation: 8.