FDA 510(k) Application Details - K241335

Device Classification Name	More FDA Info for this Device
510(K) Number	K241335
Device Name	Eversense 365 Continuous Glucose Monitoring (CGM) System
Applicant	Senseonics, Incorporated 20451 Seneca Meadows Parkway Germantown, MD 20876-7005 US Other 510(k) Applications for this Company
Contact	Mukul Jain Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SBA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/13/2024
Decision Date	09/16/2024
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