FDA 510(k) Application Details - DEN170088

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN170088
Device Name	Dexcom G6 Continuous Glucose Monitoring System
Applicant	Dexcom, Inc. 6340 Sequence Dr San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	Neeta Sharma 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	12/08/2017
Decision Date	03/27/2018
Decision	DENG -
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review