FDA 510(k) Application Details - K232804

Device Classification Name	More FDA Info for this Device
510(K) Number	K232804
Device Name	FibriCheck
Applicant	Qompium nv Kempische Steenweg 303/27 Hasselt 3500 BE Other 510(k) Applications for this Company
Contact	Jo Van der Auwera Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QME Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/12/2023
Decision Date	06/07/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review