FDA 510(k) Application Details - K132205

Device Classification Name	Generator, Oxygen, Portable   More FDA Info for this Device
510(K) Number	K132205
Device Name	Generator, Oxygen, Portable
Applicant	INOVA LABS, INC. 2800 PLEASANT HILL RD., SUITE 175 SUITE 175 PLEASANT HILL, CA 94523 US Other 510(k) Applications for this Company
Contact	PAMELA M BUCKMAN 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	07/16/2013
Decision Date	06/06/2014
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