FDA 510(k) Application Details - K031047

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K031047
Device Name	Ventilator, Non-Continuous (Respirator)
Applicant	RESMED LTD. 14040 DANIELSON ST. POWAY, CA 92064-6857 US Other 510(k) Applications for this Company
Contact	ROGER KOTTER 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	04/02/2003
Decision Date	08/19/2003
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