FDA 510(k) Application Details - K161978

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K161978
Device Name	Ventilator, Non-Continuous (Respirator)
Applicant	ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista 2153 AU Other 510(k) Applications for this Company
Contact	Kim Kuan Lee 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	07/18/2016
Decision Date	11/17/2016
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