FDA 510(k) Application Details - K121597

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K121597
Device Name	Ventilator, Non-Continuous (Respirator)
Applicant	FISHER & PAYKEL HEALTHCARE LIMITED 15 MAURICE PAYKEL PLACE EAST TAMAKI AUCKLAND 2013 NZ Other 510(k) Applications for this Company
Contact	JAMES THOMPSON 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	05/31/2012
Decision Date	10/02/2012
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