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K Number
K233861Device Name
Libre Rio Continuous Glucose Monitoring System
Manufacturer
Date Cleared
2024-06-07
(184 days)
Product Code
Regulation Number
862.1355Why did this record match?
Product Code :
SBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Libre Rio Continuous Glucose Monitoring System is an over-the-counter (OTC) integrated continuous glucose monitoring (iCGM) device indicated for non-insulin using persons age 18 and older. The System detects trends and tracks patterns and aids in the detection of euglycemia, and hypoglycemia. The System is also intended to autonomously communicate with digitally connected devices.
Device Description
The Libre Rio Continuous Glucose Monitoring System (herein referred to as the 'System') is an integrated continuous glucose monitoring system (iCGM) that provides continuous glucose measurements every minute to facilitate calculation of glucose values accompanied by trend information (glucose arrows) and historical glucose information (glucose graph). The System is intended for over-the-counter use in a home setting. The System consists of the following components: a Sensor which transmits via Bluetooth Low Energy (BLE), and a mobile application Libre Rio App that is downloaded to a compatible smartphone running iOS and Android operating system.
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