FDA 510(k) Application Details - K082829

Device Classification Name	Medevac Use Oxygen Generator   More FDA Info for this Device
510(K) Number	K082829
Device Name	Medevac Use Oxygen Generator
Applicant	CARLETON LIFE SUPPORT SYSTEMS INC. 2734 HICKORY GROVE RD. DAVENPORT, IA 52804-1203 US Other 510(k) Applications for this Company
Contact	GARY BYRD Other 510(k) Applications for this Contact
Regulation Number	868.5440   More FDA Info for this Regulation Number
Classification Product Code	OLF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/25/2008
Decision Date	12/22/2008
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	Y