FDA 510(k) Application Details - K152258

Device Classification Name	More FDA Info for this Device
510(K) Number	K152258
Device Name	T3 Software
Applicant	ETIOMETRY, INC. 119 BRAINTREE STREET SUITE 210 BOSTON, MA 02134 US Other 510(k) Applications for this Company
Contact	DIMITAR BARONOV Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PLB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/11/2015
Decision Date	03/31/2016
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