Dexcom G7 15 Day Continuous Glucose Monitoring System
FDA 510(k)Class II (US FDA 510(k))
by Dexcom, Inc.
Identifiers
- 510(k) Number
- K243214 FDA 510(k)
- FDA Product Code
- QBJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1355 FDA 510(k)
- Regulation Number
- 862.1355 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Dexcom G7 15 Day Continuous Glucose Monitoring System is a device that provides real-time glucose readings for up to 15.5 days. It is an integrated, factory-calibrated continuous glucose monitoring system designed to monitor glucose levels in patients with diabetes.
The system is supplied as a Class II medical device with FDA 510K clearance. It is intended for single-use and should be stored according to manufacturer instructions. The device is not MRI conditional and requires no special preparation for use with MRI scans.
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: Dexcom Continuous Glucose Monitoring - The most accurate CGM system ..., What is the Dexcom G7 15 Day System? - Dexcom Provider, PDF Dexcom G7 and G7 15 Day Continuous Glucose Monitoring (CGM) Systems
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243214 | Class II | Active |
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Manufacturer
- Manufacturer
- Dexcom, Inc.
Sources (1)
- FDA 510(k) K243214 24 fields · synced Oct 6, 2026