Zero-Click Data Management System, Model 8000-01528
FDA 510(k)Class II (US FDA 510(k))
by Agamatrix
Identifiers
- 510(k) Number
- K062434 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 Zero-Click Data Management System, Model 8000-01528 is a data management software accessory designed for use with the Liberty Blood Glucose Monitoring System. It functions as a desktop solution that allows users to automatically download blood glucose readings from the meter to a personal computer without manual input.
This system is supplied as a software accessory and requires a specific cable for operation. The device has received FDA 510(k) clearance and is classified under the product code NBW for blood glucose test systems.
Frequently asked questions
What is the primary function of the Zero-Click Data Management System?
This software accessory is designed to automatically download blood glucose readings from the Liberty Blood Glucose Monitoring System to a personal computer. By automating this process, it eliminates the need for manual data entry.
What equipment is required to use this software?
The system operates as a desktop solution and requires a specific cable to connect the Liberty Blood Glucose Monitoring System to your personal computer for data transfer.
Has this device received regulatory authorization?
Yes, the Zero-Click Data Management System, Model 8000-01528, has received FDA 510(k) clearance. It is classified under the product code NBW for blood glucose test systems.
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: Zero-click Data Management System, Model 8000-01528, Zero Click — AgaMatrix, 510(k) Premarket Notification, ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528… - 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 | K062434 | Class II | Active |
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Manufacturer
- Manufacturer
- Agamatrix
Sources (1)
- FDA 510(k) K062434 24 fields · synced Sep 26, 2026