FDA 510(k) Application Details - K160945

Device Classification Name	Computer, Blood-Pressure   More FDA Info for this Device
510(K) Number	K160945
Device Name	Computer, Blood-Pressure
Applicant	ENDOPHYS HOLDINGS, LLC 1601 ELM STREET Dallas, TX 75201 US Other 510(k) Applications for this Company
Contact	Rebecca K. Pine Other 510(k) Applications for this Contact
Regulation Number	870.1110   More FDA Info for this Regulation Number
Classification Product Code	DSK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/05/2016
Decision Date	09/26/2016
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