Contour Next EZ Blood Glucose Monitoring System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K162336 FDA 510(k)
- FDA Product Code
- NBW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1345 FDA 510(k)
- Regulation Number
- 862.1345 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Contour Next EZ Blood Glucose Monitoring System is a device used for measuring blood glucose levels. It features No Coding technology to eliminate errors due to user miscoding and Second-Chance Sampling technology to reduce wasted test strips.
This system is supplied as a blood glucose monitoring kit and is intended for single-use testing. It received FDA 510(k) clearance with decision code SESE on January 12, 2017, and is classified under product code NBW. The device is designed for easy-to-read display with simple test strip insertion for checking blood glucose levels.
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: Glucometer: Blood Glucose Monitoring System | CONTOUR®NEXT EZ, CONTOUR®NEXT EZ - HCP | Ascensia Diabetes Care, Glucose Meters and Test Strips | Ascensia Diabetes Care, Ascensia CONTOUR NEXT EZ Blood Glucose Monitoring System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K162336 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ascensia Diabetes Care U.S., Inc.
Sources (1)
- FDA 510(k) K162336 24 fields · synced Oct 6, 2026