FDA 510(k) Application Details - K243214

Device Classification Name	More FDA Info for this Device
510(K) Number	K243214
Device Name	Dexcom G7 15 Day Continuous Glucose Monitoring System
Applicant	Dexcom, Inc. 6340 Sequence Drive San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	Holly Drake 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	10/03/2024
Decision Date	04/09/2025
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