FDA 510(k) Application Details - K123149

Device Classification Name	Ventilator, Continuous, Facility Use   More FDA Info for this Device
510(K) Number	K123149
Device Name	Ventilator, Continuous, Facility Use
Applicant	MAQUET CRITICAL CARE AB 45 BARBOUR POND DRIVE WAYNE, NJ 07470 US Other 510(k) Applications for this Company
Contact	WHITNEY TORNING 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	10/05/2012
Decision Date	06/20/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review