FDA 510(k) Application Details - K111148

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K111148
Device Name	Ventilator, Non-Continuous (Respirator)
Applicant	RESMED CORP. 9001 SPECTRUM CENTER BOULEVARD KEARNY MESA, CA 92123 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	04/22/2011
Decision Date	06/30/2011
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