Tandem Mobi insulin pump with interoperable technology

Tandem Mobi insulin pump with interoperable technology is an FDA 510(k)-cleared medical device (K233044) 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 October 4, 2023. Regulation: 8.