
Livongo Health, Inc.
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Livongo Blood Glucose Monitoring System (BG1000) is an FDA 510(k)-cleared medical device (K200277) manufactured by Livongo Health, 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 June 3, 2020. Regulation: 8.