
N.I. Medical, Ltd.
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BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM is an FDA 510(k)-cleared medical device (K080941) manufactured by N.I. Medical, Ltd.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 17, 2009. Regulation: 8.