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510(k) Data Aggregation
K Number
K132272Device Name
GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION
Manufacturer
GLOOKO, INC.
Date Cleared
2013-10-17
(87 days)
Product Code
NBW, JOP
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
GLOOKO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Glooko device system for Glooko Application is data management software intended for use in home and professional settings to aid individuals with diabetes and their health care professionals in review, analysis and evaluation of blood glucose readings to support an effective diabetes management program. The Glooko device system for Glooko Application connects to compatible FDA cleared meters and allows users to transfer their blood glucose meter results to their mobile devices running on Android Operating System.
The Glooko device system for Glooko Application is not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice.
Device Description
The Glooko device system for Glooko Application is used to aid individuals with diabetes in the download, review, analysis, evaluation, and communication of their blood glucose readings. The system allows users to download readings from compatible, FDA-cleared, commercial blood glucose meters to their Android Operating System mobile devices, and then share this information with healthcare professionals. It is intended for use both in home and professional settings to support an effective diabetes management program. The data may be displayed on supported devices to provide an online view of all collected data and notes from the Glooko Android Application. The system does not provide treatment decisions and cannot be used as a substitute for professional healthcare advice.
The Glooko device system for Glooko Application consists of the following components:
1. The Glooko MeterSync Cable for Android
2. The Glooko Application
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K Number
K130886Device Name
GLOOKO DEVICE SYSTEM FOR GLOOKO LOGBOOK+ APPLICATION
Manufacturer
GLOOKO, INC.
Date Cleared
2013-04-25
(27 days)
Product Code
NBW, JQP
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
GLOOKO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Glooko device system for Glooko Logbook+ Application is a data management software intended for use in home and professional settings to aid individuals with diabetes and their health care professionals in review, analysis and evaluation of blood glucose readings to support an effective diabetes management program. The Glooko device system for Glooko Logbook+ Application connects to compatible FDA cleared meters and allows users to transfer their blood glucose meter results to their iPhone operating system platform.
The Glooko device system for Glooko Loabook+ Application is not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice.
Device Description
The Glooko device system for Glooko Logbook+ Application is used to aid individuals with diabetes in the download, review, analysis, evaluation, and communication of their blood glucose readings. The system allows users to download readings from compatible, FDA-cleared, commercial blood glucose meters to their iPhone Operating System (iOS) devices, and then share this information with healthcare professionals. It is intended for use both in home and professional settings to support an effective diabetes management program. The data may be displayed on supported devices to provide an online view of all collected data and notes from the Glooko Logbook+ Application. The system does not provide treatment decisions and cannot be used as a substitute for professional healthcare advice.
The Glooko device system for Logbook+ Application consists of the following components:
1. The Glooko MeterSync Cable
2. The Glooko IR Adapter
3. The Glooko Logbook+ Application
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K Number
K122142Device Name
GLOOKO LOGBOOK CHARTS
Manufacturer
GLOOKO, INC.
Date Cleared
2012-12-21
(155 days)
Product Code
NBW, JQP
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
GLOOKO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Glooko device system for the Glooko Logbook Application and Glooko Logbook Charts is data management software intended for use in home and professional settings to aid individuals with diabetes and their health care professionals in review, analysis and evaluation of blood glucose readings to support an effective diabetes management program. The Glooko device system for the Glooko Logbook Application connects to compatible FDA cleared meters and allows users to transfer their blood glucose meter results to their iPhone operating system platform.
The Glooko device system for the Glooko Logbook Application and Glooko Logbook Charts are not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice.
Device Description
The Glooko device system for the Glooko Logbook Application includes the following:
- . Glooko MeterSync Cable
- . Glooko IR Adapter
- . Glooko Logbook Application
The Glooko™ Logbook Charts is a data management software tool designed to assist people with diabetes who self-manage their Blood Glucose (BG) readings. The Logbook Charts software is used in conjunction with the Glooko MeterSync Cable and the Glooko Logbook Application. The MeterSync Cable and the Glooko Logbook Application allow users to download BG readings from commercially available blood glucose meters to an iOS (iPhone Operating System) device. The Glooko Logbook Charts software tool enables the Glooko Logbook Application users to chart and graph their BG values from the Glooko Logbook Application. Glooko Logbook Charts is a spreadsheet program developed in Microsoft Excel and helps with quantitatively evaluating the BG data downloaded into the Glooko Logbook Application. Users can download the Glooko Logbook Charts sheet template from the Glooko website to generate and display reports on average BG values and BG trends. Several statistical parameters are calculated and the data is plotted as scattergrams relating blood glucose by time of day and by date. Glooko Logbook Charts specifically offers the following charts and table for view:
- a. BG readings By Time of Day: provides an overview of glucose readings during the day.
- BG readings By Dote: provides an overview of glucose readings over a specified date b. range.
- ﻥ BG readings Analysis By Time Of Day: provides an overview of analyzed glucose readings during the day with high and low values, percentiles, mean and medians. BG readings Summary Statistics: provides an overview of the analyzed glucose readings in table format.
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