FDA 510(k) Application Details - K161487

Device Classification Name	Ventilator, Continuous, Non-Life-Supporting   More FDA Info for this Device
510(K) Number	K161487
Device Name	Ventilator, Continuous, Non-Life-Supporting
Applicant	ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 AU Other 510(k) Applications for this Company
Contact	Jasjit Baveja 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	05/31/2016
Decision Date	09/09/2016
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