
Hypoguard USA, Inc.
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GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020 is an FDA 510(k)-cleared medical device (K022545) manufactured by Hypoguard USA, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 10, 2002. Regulation: 8.