FDA 510(k) Application Details - K081321

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K081321
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	DAVID D'CRUZ 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	05/12/2008
Decision Date	10/09/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review