T:SLIM Insulin Delivery System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K133593 FDA 510(k)
- FDA Product Code
- LZG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5725 FDA 510(k)
- Regulation Number
- 880.5725 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The T:SLIM Insulin Delivery System is an insulin pump designed for diabetes management. It is a Class II medical device that delivers insulin continuously or as a basal insulin protector.
The device is manufactured by Tandem Diabetes Care, Inc. and has FDA 510(k) clearance with product code LZG. It is intended for use in a general hospital setting and is not specified as single-use or reusable.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: t:slim X2 Insulin Pump | Tandem Diabetes Care, Control-IQ Technology | Tandem Diabetes Care, TANDEM T:SLIM USER MANUAL Pdf Download | ManualsLib, TANDEM T-SLIM X2 USER MANUAL Pdf Download | ManualsLib
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K133593 | Class II | Active |
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Manufacturer
- Manufacturer
- Tandem Diabetes Care, Inc.
Sources (1)
- FDA 510(k) K133593 24 fields · synced Oct 6, 2026