FDA 510(k) Application Details - K111595

Device Classification Name	Ventilator, Continuous, Facility Use   More FDA Info for this Device
510(K) Number	K111595
Device Name	Ventilator, Continuous, Facility Use
Applicant	TECME S.A. 79 BROOKLINE ROAD MASON, NH 03048 US Other 510(k) Applications for this Company
Contact	Ray Kelly 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	06/07/2011
Decision Date	01/27/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review