Glooko Logbook Charts
by Glooko, Inc.
510(k) K122142
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK122142 | Date21 Dec 2012 | StatusActive |
Official records
- FDA 510(k) database K122142
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- NBW
- Device class
- Class II
- Regulation
- 21 CFR Part 862.1345
- Advisory committee
- Clinical Chemistry
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 26 Sep 2026
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.
From the manufacturer
The short video below details the features and data available on the Logbook tab.
Similar devices
Other devices filed under FDA product code NBW (System, Test, Blood Glucose, Over The Counter).
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- ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM by Acon Laboratories, Inc.
- EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008 by EPS BIO TECHNOLOGY CORP.
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