FDA 510(k) Application Details - K161492

Device Classification Name	Ventilator, Continuous, Non-Life-Supporting   More FDA Info for this Device
510(K) Number	K161492
Device Name	Ventilator, Continuous, Non-Life-Supporting
Applicant	ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista 2153 AU Other 510(k) Applications for this Company
Contact	Jean-Nicolas Boudaud 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	06/01/2016
Decision Date	01/19/2017
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