FDA 510(k) Application Details - K193642

Device Classification Name	More FDA Info for this Device
510(K) Number	K193642
Device Name	Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System
Applicant	Dexcom, Inc. 6340 Sequence Drive San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	Linda Wang Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QDK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/30/2019
Decision Date	01/29/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review