FDA 510(k) Application Details - K131990

Device Classification Name	Generator, Oxygen, Portable   More FDA Info for this Device
510(K) Number	K131990
Device Name	Generator, Oxygen, Portable
Applicant	ESSEX CRYOGENICS OF MISSOURI, INC. 8007 CHIVVIS DR. ST. LOUIS, MO 63123 US Other 510(k) Applications for this Company
Contact	PAUL DRYDEN 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	06/28/2013
Decision Date	02/21/2014
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