FDA 510(k) Application Details - K231091

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K231091
Device Name	Computer, Diagnostic, Programmable
Applicant	Acutus Medical Inc 2210 Faraday Ave, Suite 100 Carlsbad, CA 92008 US Other 510(k) Applications for this Company
Contact	Karla Schaffner Other 510(k) Applications for this Contact
Regulation Number	870.1425   More FDA Info for this Regulation Number
Classification Product Code	DQK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/17/2023
Decision Date	07/10/2023
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