FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE), (BCI-COMPATIBLE), (DATEX-COMPATIBLE)

FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE), (BCI-COMPATIBLE), (DATEX-COMPATIBLE) is an FDA 510(k)-cleared medical device (K041644) manufactured by Elekon Industries U.S.A., 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 July 28, 2004. Regulation: 8.