510(k) K162080
K162080 is an FDA 510(k) premarket notification submitted by Tandem Diabetes Care, Inc. for the device "t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater". The FDA issued a decision of Substantially Equivalent on October 25, 2016. The device falls under product code LZG (Pump, Infusion, Insulin), a Class II device regulated under 21 CFR 880.5725. Tandem Diabetes Care, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 25, 2016
- Date Received
- July 27, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Infusion, Insulin
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- CH
- Submission Type