FDA 510(k) Application Details - K081779

Device Classification Name	Unit, Liquid-Oxygen, Portable   More FDA Info for this Device
510(K) Number	K081779
Device Name	Unit, Liquid-Oxygen, Portable
Applicant	RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY MONROEVILLE, PA 15146 US Other 510(k) Applications for this Company
Contact	ZITA A YURKO Other 510(k) Applications for this Contact
Regulation Number	868.5655   More FDA Info for this Regulation Number
Classification Product Code	BYJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/23/2008
Decision Date	09/19/2008
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