Connect Data Management System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K994433 FDA 510(k)
- FDA Product Code
- LFR 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 Connect Data Management System is a device designed for the management of glucose data. It functions as a tool to assist in the tracking and organization of information related to glucose levels.
This system is authorized under FDA 510k clearance. It is intended for use in clinical settings to support the processing of data associated with glucose monitoring.
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: Integrated Data Connect Diabetes Care - Abbott U.S., Helping people manage diabetes with more confidence, Connected Care - FreeStyle Libre | Abbott, Abbott Diabetes Products | FreeStyle Libre CGM Systems, Abbott FreeStyle Precision Pro Operator's Manual
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K994433 | Class II | Active |
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Manufacturer
- Manufacturer
- Abbott Diabetes Care Inc
- FDA Applicant
- Abbott Diabetes Care, Inc.
Sources (1)
- FDA 510(k) K994433 24 fields · synced Sep 25, 2026