Clever Chek Auto-Code Voice Blood Glucose Monitoring System, Model TD-4243
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K081144 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 Clever Chek Auto-Code Voice Blood Glucose Monitoring System, Model TD-4243, is a medical device designed for the quantitative measurement of glucose in fresh capillary whole blood. It provides users with an automated method for monitoring blood sugar levels.
This device has received FDA 510k clearance under the product code NBW. It is manufactured by TaiDoc Technology Corporation and is intended for clinical chemistry applications.
Frequently asked questions
What is the primary function of the Clever Chek TD-4243?
The Clever Chek Auto-Code Voice Blood Glucose Monitoring System is designed for the quantitative measurement of glucose levels in fresh capillary whole blood, providing users with an automated monitoring solution.
What is the regulatory status of this monitoring system?
This device has received FDA 510k clearance under product code NBW, indicating it has been reviewed and found substantially equivalent to legally marketed predicate devices for clinical chemistry applications.
Who is the manufacturer of this blood glucose monitor?
The device is manufactured by TaiDoc Technology Corporation, located in New Taipei City, Taiwan.
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: Clever Chek Auto-code Voice Blood Glucose Monitoring System, Model Td ..., Clever Chek Auto-code Voice Blood Glucose Monitoring System, Model Td ..., PDF K081144 Clever Chek Auto-code Voice Blood Glucose Monitoring System ..., Clever chek manuals - Manuals Warehouse
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K081144 | Class II | Active |
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Manufacturer
- Manufacturer
- Taidoc Technology Corporation
Sources (1)
- FDA 510(k) K081144 24 fields · synced Sep 21, 2026