FDA 510(k) Application Details - K113801

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K113801
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 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	12/22/2011
Decision Date	05/25/2012
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