FDA 510(k) Application Details - K143449

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K143449
Device Name	Computer, Diagnostic, Programmable
Applicant	ADAMS MEDITECH LLC 17890 Castleton Street, Suite 302 City of Industry, CA 91748 US Other 510(k) Applications for this Company
Contact	CECILIA L. YU 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	12/02/2014
Decision Date	06/26/2015
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