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ImpediMed Limited
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IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400 is an FDA 510(k)-cleared medical device (K100811) 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 November 3, 2011. Regulation: 8.