Glooko Logbook Charts
FDA 510(k)Class II (US FDA 510(k))
by Glooko, Inc.
Identifiers
- 510(k) Number
- K122142 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)
Glooko Logbook Charts is data management software designed to assist individuals with diabetes and their healthcare professionals. The system facilitates the review, analysis, and evaluation of blood glucose readings to support effective diabetes management programs.
This device allows users to download readings from compatible, FDA-cleared commercial blood glucose meters for use in both home and professional settings. The system is authorized under FDA 510(k) clearance K122142.
Frequently asked questions
What is the purpose of Glooko Logbook Charts?
This software is designed to assist individuals with diabetes and their healthcare providers by facilitating the review, analysis, and evaluation of blood glucose readings to support diabetes management programs.
How does the software collect blood glucose data?
The system allows users to download blood glucose readings directly from compatible, FDA-cleared commercial blood glucose meters for use in both home and professional clinical settings.
Is this software authorized for use?
Yes, Glooko Logbook Charts is authorized under FDA 510(k) clearance number K122142, which indicates it has been found substantially equivalent to other legally marketed devices.
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: GLOOKO LOGBOOK CHARTS by GLOOKO, INC. | FDA 510 (k) Summary, PDF glQ1 Glooko Device system for Glooko Logbook- Application owkbW ?, 510 ..., Training Video: Logbook Tab - Glooko Support | Help Center
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K122142 | Class II | Active |
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Manufacturer
- Manufacturer
- Glooko, Inc.
Sources (1)
- FDA 510(k) K122142 24 fields · synced Sep 26, 2026