510(k) K141758
K141758 is an FDA 510(k) premarket notification submitted by Tandem Diabetes Care, Inc. for the device "T:SLIM INSULIN DELIVERY SYSTEM". The FDA issued a decision of Substantially Equivalent on October 31, 2014. 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 31, 2014
- Date Received
- June 30, 2014
- 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