FDA 510(k) Application Details - DEN230006

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN230006
Device Name	esolution
Applicant	S4 Medical Corp 34 S Main Street Suite 200 Chagrin Falls, OH 44022 US Other 510(k) Applications for this Company
Contact	William Fuller Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QXU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/24/2023
Decision Date	09/06/2023
Decision	DENG -
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review