FDA 510(k) Application Details - K173483

Device Classification Name	Device, Counter-Pulsating, External   More FDA Info for this Device
510(K) Number	K173483
Device Name	Device, Counter-Pulsating, External
Applicant	Xtreem Pulse, LLC 353 W 29 St., Suite 3 New York, NY 10001 US Other 510(k) Applications for this Company
Contact	Andrew Barile Other 510(k) Applications for this Contact
Regulation Number	870.5225   More FDA Info for this Regulation Number
Classification Product Code	DRN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/13/2017
Decision Date	05/30/2018
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