
Tandem Diabetes Care, Inc.
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t:slim X2 Insulin Pump with Interoperable Technology is an FDA 510(k)-cleared medical device (K232380) manufactured by Tandem Diabetes Care, 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 November 2, 2023. Regulation: 8.