FDA 510(k) Application Details - K162877

Device Classification Name	Ventilator, Continuous, Facility Use   More FDA Info for this Device
510(K) Number	K162877
Device Name	Ventilator, Continuous, Facility Use
Applicant	VENTEC LIFE SYSTEMS, INC 19021 120TH AVE NE SUITE 101 BOTHELL, WA 98011 US Other 510(k) Applications for this Company
Contact	Joseph Cipollone Other 510(k) Applications for this Contact
Regulation Number	868.5895   More FDA Info for this Regulation Number
Classification Product Code	CBK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/14/2016
Decision Date	04/07/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review