FDA 510(k) Application Details - K170565

Device Classification Name	More FDA Info for this Device
510(K) Number	K170565
Device Name	LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L
Applicant	LifeWatch Services, Inc 10255 W Higgins Road Suite 100 Rosemont, IL 60018 US Other 510(k) Applications for this Company
Contact	Stefanie Martinez-Koenig Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QYX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/27/2017
Decision Date	08/01/2017
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