FDA 510(k) Application Details - K063404

Device Classification Name	Ventilator, Continuous, Facility Use   More FDA Info for this Device
510(K) Number	K063404
Device Name	Ventilator, Continuous, Facility Use
Applicant	MAQUET CRITICAL CARE AB 1140 ROUTE 22 EAST SUITE 202 BRIDGEWATER, NJ 08807 US Other 510(k) Applications for this Company
Contact	JAMIE YIEH 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	11/09/2006
Decision Date	02/15/2007
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