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Dexcom G6 Continuous Glucose Monitoring (CGM) System

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
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)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
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