FDA 510(k) Application Details - K133305

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K133305
Device Name	Computer, Diagnostic, Programmable
Applicant	TOPERA, INC. 3668 S. GEYER ROAD SUITE 365 ST. LOUIS, MO 63127 US Other 510(k) Applications for this Company
Contact	DENNIS POZZO 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	10/28/2013
Decision Date	12/16/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review