FDA 510(k) Application Details - K181042

Device Classification Name	Echocardiograph   More FDA Info for this Device
510(K) Number	K181042
Device Name	Echocardiograph
Applicant	Boston Scientific Corporation 3 Scimed Place Maple Grove, MN 55311 US Other 510(k) Applications for this Company
Contact	Jennifer L. Foley 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	04/19/2018
Decision Date	05/17/2018
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