Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System— 510(k) K193642

Substantially Equivalent

Dexcom, Inc.

FDA 510(k) clearance K193642 for Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, Substantially Equivalent on 2020-01-29. Applicant: Dexcom, Inc..

Clearance details

Applicant: Dexcom, Inc.
Product code: Code QDK
Advisory panel: Clinical Chemistry
Date received: 2019-12-30
Decision date: 2020-01-29
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code QDK

product code QDK

Malfunction: 578
Total: 578

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.