FDA 510(k) Application Details - K160173

Device Classification Name	Echocardiograph   More FDA Info for this Device
510(K) Number	K160173
Device Name	Echocardiograph
Applicant	Boston Scientific Corporation 47215 Lakeview Boulevard Fremont, CA 94538 US Other 510(k) Applications for this Company
Contact	Eric Elliott Other 510(k) Applications for this Contact
Regulation Number	870.2330   More FDA Info for this Regulation Number
Classification Product Code	DXK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/27/2016
Decision Date	02/26/2016
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