SBH

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter

Device class

Class II (moderate risk)

Regulation

21 CFR 862.1355

Medical specialty

Clinical Chemistry

FDA definition

An integrated continuous glucose monitoring system (iCGM) for non-intensive glucose management is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time to detect euglycemic and dysglycemic glucose levels across the range spanning clinically significant hypoglycemia and hyperglycemia levels in persons who are not on insulin and who do not have a significant risk of problematic hypoglycemia. iCGM systems for non-intensive glucose management are designed to reliably and securely transmit glucose measurement data to digitally connected devices, excluding devices intended to control the delivery of insulin, and are intended to be used alone or in conjunction with these digitally connected medical devices.

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