CAPILLARYS NEONAT HB (PN 2006)

CAPILLARYS NEONAT HB (PN 2006) is an FDA 510(k)-cleared medical device (K091283) manufactured by Sebia. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 21, 2010. Regulation: 8.