FDA 510(k) Application Details - K052396

Device Classification Name	Generator, Oxygen, Portable   More FDA Info for this Device
510(K) Number	K052396
Device Name	Generator, Oxygen, Portable
Applicant	OXYSURE SYSTEMS, INC. 2611 INTERNET BLVD., SUITE 109 FRISCO, TX 75034 US Other 510(k) Applications for this Company
Contact	JULIAN T ROSS 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	08/31/2005
Decision Date	12/09/2005
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