510(k) K182405

Dexcom Pro Q Continuous Glucose Monitoring System by Dexcom, Inc. — Product Code QDL

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 2, 2018
Date Received: September 4, 2018
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Integrated Continuous Glucose Monitoring System For Professional Retrospective Use
Device Class: Class II
Regulation Number: 862.1355
Review Panel: CH
Submission Type

An integrated continuous glucose monitoring system for professional retrospective use is a continuous glucose recording device indicated for the retrospective discovery, analysis, and interpretation of glycemic variability in persons age 2 and older for use by healthcare professionals to guide appropriate patient management. The system is also intended to interface with digitally connected devices.

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