
Galix Biomedical Instrumentation, Inc.
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3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM is an FDA 510(k)-cleared medical device (K092853) 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 July 8, 2010. Regulation: 8.