FDA 510(k) Application Details - DEN200030

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN200030
Device Name	FEops HEARTguide
Applicant	FEops NV Technologiepark 122 Gent 9052 BE Other 510(k) Applications for this Company
Contact	Sofie Van Cauter Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QQI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/07/2020
Decision Date	09/08/2021
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