FDA 510(k) Application Details - K123557

Device Classification Name	Ventilator, Continuous, Non-Life-Supporting   More FDA Info for this Device
510(K) Number	K123557
Device Name	Ventilator, Continuous, Non-Life-Supporting
Applicant	RESMED LTD. 9001 SPECTRUM CENTER BLVD. SAN DIEGO, CA 92123 US Other 510(k) Applications for this Company
Contact	JIM CASSI Other 510(k) Applications for this Contact
Regulation Number	868.5895   More FDA Info for this Regulation Number
Classification Product Code	MNS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/19/2012
Decision Date	03/14/2013
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