FDA 510(k) Application Details - K043120

Device Classification Name	Filter, Bacterial, Breathing-Circuit   More FDA Info for this Device
510(K) Number	K043120
Device Name	Filter, Bacterial, Breathing-Circuit
Applicant	DATEX-OHMEDA, INC. 86 PILGRIM RD. NEEDHAM, MA 02492 US Other 510(k) Applications for this Company
Contact	JOEL KENT Other 510(k) Applications for this Contact
Regulation Number	868.5260   More FDA Info for this Regulation Number
Classification Product Code	CAH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/12/2004
Decision Date	03/01/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review