FDA 510(k) Application Details - K051550

Device Classification Name	Ventilator, Continuous, Facility Use   More FDA Info for this Device
510(K) Number	K051550
Device Name	Ventilator, Continuous, Facility Use
Applicant	EVENT MEDICAL LTD. 6A LIOSBAN BUSINESS PARK TUAM ROAD GALWAY IE Other 510(k) Applications for this Company
Contact	ROBBIE WALSH 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	06/13/2005
Decision Date	07/12/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review