FDA 510(k) Application Details - K162433

Device Classification Name	Generator, Oxygen, Portable   More FDA Info for this Device
510(K) Number	K162433
Device Name	Generator, Oxygen, Portable
Applicant	OXUS, INC 2676 PALDAN AUBURN HILLS, MI 48326 US Other 510(k) Applications for this Company
Contact	RYAN LENARCIC Other 510(k) Applications for this Contact
Regulation Number	868.5440   More FDA Info for this Regulation Number
Classification Product Code	CAW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/31/2016
Decision Date	05/24/2017
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