FDA 510(k) Application Details - K201328

Device Classification Name	More FDA Info for this Device
510(K) Number	K201328
Device Name	Dexcom G6 Continuous Glucose Monitoring (CGM) System
Applicant	Dexcom, Inc. 6310 Sequence Dr. San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	Maryam Amini Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QBJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/19/2020
Decision Date	07/15/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review