FDA 510(k) Application Details - K113640

Device Classification Name	Ventilator, Continuous, Minimal Ventilatory Support,Facility Use   More FDA Info for this Device
510(K) Number	K113640
Device Name	Ventilator, Continuous, Minimal Ventilatory Support,Facility Use
Applicant	RESMED GERMANY INC. 9001 SPECTRUMA CENTER BOULEVARD SAN DIEGO, CA 92123 US Other 510(k) Applications for this Company
Contact	DAVID D'CRUZ Other 510(k) Applications for this Contact
Regulation Number	868.5895   More FDA Info for this Regulation Number
Classification Product Code	MNT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/09/2011
Decision Date	04/05/2012
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