FDA 510(k) Application Details - K183512

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K183512
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	Nerida Hunt 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	12/18/2018
Decision Date	05/07/2019
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