FDA 510(k) Application Details - K180805

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K180805
Device Name	Computer, Diagnostic, Programmable
Applicant	BioSig Technologies 12424 Wilshire Blvd, Suite 745 Los Angeles, CA 90025 US Other 510(k) Applications for this Company
Contact	Tiffini Wittwer 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	03/28/2018
Decision Date	08/08/2018
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