FDA 510(k) Application Details - K081206

Device Classification Name	Generator, Oxygen, Portable   More FDA Info for this Device
510(K) Number	K081206
Device Name	Generator, 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	868.5440   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	04/29/2008
Decision Date	07/28/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review