FDA 510(k) Application Details - K133666

Device Classification Name	Filter, Bacterial, Breathing-Circuit   More FDA Info for this Device
510(K) Number	K133666
Device Name	Filter, Bacterial, Breathing-Circuit
Applicant	FISHER & PAYKEL HEALTHCARE LTD. 15 MAURICE PAYKEL PLACE, EAST TAMAKI AUCKLAND 2013 NZ Other 510(k) Applications for this Company
Contact	ELIZABETH GOLDSTEIN 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	11/29/2013
Decision Date	02/05/2014
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