FDA 510(k) Application Details - K172493

Device Classification Name	More FDA Info for this Device
510(K) Number	K172493
Device Name	EnsoETM
Applicant	Attune Medical 3440 S. Dearborn St. #215-South Chicago, IL 60616 US Other 510(k) Applications for this Company
Contact	Erik Kulstad Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PLA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/18/2017
Decision Date	10/17/2017
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