Clever Chek Health Care System Software Version 1.0
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K070941 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)
Clever Chek Health Care System Software Version 1.0 is an optional data management accessory for specific TaiDoc blood glucose and blood pressure monitoring devices. It functions by transferring stored test data from the meter's memory to a computer.
The software is used in home and clinical settings by patients and healthcare professionals to review, analyze, and evaluate historical test data. It is supplied as a software accessory and is authorized under FDA 510(k) clearance K070941 with product code NBW.
Frequently asked questions
What is the Clever Chek Health Care System Software Version 1.0 used for?
The software is used to transfer stored test data from specific TaiDoc blood glucose and blood pressure monitoring devices to a computer, allowing patients and healthcare professionals to review, analyze, and evaluate historical test data in home and clinical settings.
How is the Clever Chek Health Care System Software Version 1.0 supplied?
The software is supplied as a data management accessory that connects to compatible TaiDoc monitoring devices to enable transfer of stored test results to a computer for further review and analysis.
Is the Clever Chek Health Care System Software Version 1.0 intended for single-use or reuse?
The software is designed for reuse as it is installed on a computer and can be used repeatedly to transfer and manage data from multiple monitoring sessions over time.
What regulatory authorization does the Clever Chek Health Care System Software Version 1.0 have?
The software is authorized under FDA 510(k) clearance K070941 with product code NBW, indicating it was found substantially equivalent to a legally marketed predicate device.
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 Health Care System Software, Version 1.0 (K070941) — Fda ..., CLEVER CHEK HEALTH CARE SYSTEM SOFTWARE, VERSION 1.0 by TaiDoc ..., CLEVER CHEK HEALTH CARE SYSTEM SOFTWARE, VERSION 1.0… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K070941 | Class II | Active |
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Manufacturer
- Manufacturer
- Taidoc Technology Corporation
Sources (1)
- FDA 510(k) K070941 24 fields · synced Sep 24, 2026