FDAnews
www.fdanews.com/articles/102016-bmeye-announces-fda-510-k-clearance-for-nexfin

BMEYE Announces FDA 510(K) Clearance for Nexfin

December 10, 2007
BMEYE announced that it has received 510(K) clearance from the U.S. Food and Drug Administration (FDA) to market Nexfin, its newly developed line of safe, precise and easy to use hemodynamic monitors.
Earthtimes.org