FDA 510(k) Application Details - K152582

Device Classification Name	Computer, Blood-Pressure   More FDA Info for this Device
510(K) Number	K152582
Device Name	Computer, Blood-Pressure
Applicant	VOLCANO CORPORATION 3721 VALLEY CENTRE DR STE 500 SAN DIEGO, CA 92130 US Other 510(k) Applications for this Company
Contact	NATHAN DA SILVA Other 510(k) Applications for this Contact
Regulation Number	870.1110   More FDA Info for this Regulation Number
Classification Product Code	DSK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/10/2015
Decision Date	12/03/2015
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