EBW NM 2.0

EBW NM 2.0 is an FDA 510(k)-cleared medical device (K111336) manufactured by Philips Medical Systems (Cleveland), Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 23, 2011. Regulation: 8.