FDA 510(k) Application Details - K061236

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K061236
Device Name	Ventilator, Non-Continuous (Respirator)
Applicant	FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE EAST TAMAKI, AUCKLAND 1701 NZ Other 510(k) Applications for this Company
Contact	REENA DAKEN Other 510(k) Applications for this Contact
Regulation Number	868.5905   More FDA Info for this Regulation Number
Classification Product Code	BZD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/03/2006
Decision Date	08/29/2006
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