FDA 510(k) Application Details - K181170

Device Classification Name	Ventilator, Continuous, Facility Use   More FDA Info for this Device
510(K) Number	K181170
Device Name	Ventilator, Continuous, Facility Use
Applicant	Respironics Inc. 1001 Murry Ridge Lane Murrysville, PA 15668 US Other 510(k) Applications for this Company
Contact	Colleen Witt Other 510(k) Applications for this Contact
Regulation Number	868.5895   More FDA Info for this Regulation Number
Classification Product Code	CBK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/02/2018
Decision Date	07/18/2019
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