Last synced on 14 November 2025 at 11:06 pm

Dexcom G6 Continuous Glucose Monitoring (CGM) System

Page Type
Cleared 510(K)
510(k) Number
K201328
510(k) Type
Traditional
Applicant
Dexcom, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/15/2021
Days to Decision
422 days
Submission Type
Summary

Dexcom G6 Continuous Glucose Monitoring (CGM) System

Page Type
Cleared 510(K)
510(k) Number
K201328
510(k) Type
Traditional
Applicant
Dexcom, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/15/2021
Days to Decision
422 days
Submission Type
Summary