FDA 510(k) Application Details - K213521

Device Classification Name	Ventilator, Continuous, Minimal Ventilatory Support,Facility Use   More FDA Info for this Device
510(K) Number	K213521
Device Name	Ventilator, Continuous, Minimal Ventilatory Support,Facility Use
Applicant	Nihon Kohden OrangeMed, Inc. 1800 E. Wilshire Avenue Santa Ana, CA 92705 US Other 510(k) Applications for this Company
Contact	Jacqueline Villanueva 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	11/03/2021
Decision Date	07/01/2022
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