FDA 510(k) Application Details - K201341

Device Classification Name	Catheter,Intracardiac Mapping,High-Density Array   More FDA Info for this Device
510(K) Number	K201341
Device Name	Catheter,Intracardiac Mapping,High-Density Array
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	870.1220   More FDA Info for this Regulation Number
Classification Product Code	MTD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/20/2020
Decision Date	09/15/2020
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