FDA 510(k) Application Details - DEN230052

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN230052
Device Name	Eversense AP 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	08/09/2023
Decision Date	04/29/2024
Decision	DENG -
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review