FDA 510(k) Application Details - K130178

Device Classification Name	Ventilator, Continuous, Facility Use   More FDA Info for this Device
510(K) Number	K130178
Device Name	Ventilator, Continuous, Facility Use
Applicant	EVENT MEDICAL LTD 971CALLE AMANECER SUITE 101 SAN CLEMENTE, CA 92673 US Other 510(k) Applications for this Company
Contact	RICK WATERS 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	01/25/2013
Decision Date	10/29/2013
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