FDA 510(k) Application Details - K081267

Device Classification Name	Generator, Oxygen, Portable   More FDA Info for this Device
510(K) Number	K081267
Device Name	Generator, Oxygen, Portable
Applicant	KEDL INTERNATION LIMITED 7690 CAMERON CIRCLE FORT MYERS, FL 33912 US Other 510(k) Applications for this Company
Contact	Lee Leichter 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	05/05/2008
Decision Date	09/23/2008
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