BM3/BM3 PLUS

BM3/BM3 PLUS is an FDA 510(k)-cleared medical device (K132033) manufactured by Noblitt & Rueland. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 3, 2013. Regulation: 8.