FDA 510(k) Application Details - K134023

Device Classification Name	Generator, Oxygen, Portable   More FDA Info for this Device
510(K) Number	K134023
Device Name	Generator, Oxygen, Portable
Applicant	ULTRA ELECTRONICS LIMITED PRECISION AIR & LAND SY ARLE COURT HATHERLEY LANE CHELTENHAM, GLOUCESTERSHIRE GL51 6PN GB Other 510(k) Applications for this Company
Contact	ANDY CHILTON 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	12/30/2013
Decision Date	04/25/2014
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