FDA 510(k) Application Details - K234133

Device Classification Name	More FDA Info for this Device
510(K) Number	K234133
Device Name	Dexcom G7 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	12/29/2023
Decision Date	02/26/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review