FDA 510(k) Application Details - K231081

Device Classification Name	More FDA Info for this Device
510(K) Number	K231081
Device Name	Dexcom G7 Continuous Glucose Monitoring (CGM) System
Applicant	Dexcom, Inc. 6340 Sequence Dr San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	Bob Shen 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	04/17/2023
Decision Date	05/15/2023
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