FDA 510(k) Application Details - K191159

Device Classification Name	Generator, Oxygen, Portable   More FDA Info for this Device
510(K) Number	K191159
Device Name	Generator, Oxygen, Portable
Applicant	Invacare Corporation One Invacare Way Elyria, OH 44035 US Other 510(k) Applications for this Company
Contact	Elijah Wreh 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	05/01/2019
Decision Date	08/29/2019
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