FDA 510(k) Application Details - K050927

Device Classification Name	Filter, Bacterial, Breathing-Circuit   More FDA Info for this Device
510(K) Number	K050927
Device Name	Filter, Bacterial, Breathing-Circuit
Applicant	FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE P.O. BOX 14-348, PANMURE EAST TAMAKI, AUCKLAND NZ Other 510(k) Applications for this Company
Contact	RENETA MONEY 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	04/13/2005
Decision Date	08/01/2005
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