SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY

SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY is an FDA 510(k)-cleared medical device (K954717) manufactured by Sodem Diffusion SA. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 21, 1997. Regulation: 8.