FDA 510(k) Application Details - K191624

Device Classification Name	Ventilator, Continuous, Minimal Ventilatory Support,Facility Use   More FDA Info for this Device
510(K) Number	K191624
Device Name	Ventilator, Continuous, Minimal Ventilatory Support,Facility Use
Applicant	Fisher & Paykel Healthcare Limited 15 Maurice Paykel Place Auckland 2013 NZ Other 510(k) Applications for this Company
Contact	Nicholas Yap Other 510(k) Applications for this Contact
Regulation Number	868.5895   More FDA Info for this Regulation Number
Classification Product Code	MNT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/18/2019
Decision Date	03/09/2020
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