Clearance Summary
t:slim X2 insulin pump with interoperable technology received FDA 510(k) clearance under submission number DEN180058, sponsored by Tandem Diabetes Care, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2019-02-14.
- Submission: DEN180058
- Applicant / Sponsor: Tandem Diabetes Care, Inc.
- Clearance pathway: Direct
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 880.5730
- Decision date: 2019-02-14
Classification & Regulation
This clearance is catalogued under FDA product code QFG and 21 CFR 880.5730, within the Clinical Chemistry review panel as a Class II device.