Clearance Summary
T:CONNECT DATA MANAGEMENT SYSTEM received FDA 510(k) clearance under submission number K122361, sponsored by Tandem Diabetes Care, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2013-02-22.
- Submission: K122361
- Applicant / Sponsor: Tandem Diabetes Care, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6310
- Decision date: 2013-02-22
Classification & Regulation
This clearance is catalogued under FDA product code OUG and 21 CFR 880.6310, within the General Hospital review panel as a Class I device.