GALIX GBI -3S-LP

GALIX GBI -3S-LP is an FDA 510(k)-cleared medical device (K992706) manufactured by Galix Biomedical Instrumentation, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 14, 2001. Regulation: 8.