FDA 510(k) Application Details - K182344

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K182344
Device Name	Computer, Diagnostic, Programmable
Applicant	Biofourmis Singapore Pte. Ltd. Vision Exchange, #07-15, 2 Venture Drive Singapore 608526 SG Other 510(k) Applications for this Company
Contact	Kuldeep Singh Rajput 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	08/28/2018
Decision Date	03/07/2019
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