
Tandem Diabetes Care, Inc.
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t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater is an FDA 510(k)-cleared medical device (K162080) manufactured by Tandem Diabetes Care, Inc.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 24, 2016. Regulation: 8.

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