IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS

IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS is an FDA 510(k)-cleared medical device (K130338) manufactured by ImpediMed Limited. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 30, 2013. Regulation: 8.