FDA 510(k) Application Details - K082345

Device Classification Name	Valve, Non-Rebreathing   More FDA Info for this Device
510(K) Number	K082345
Device Name	Valve, Non-Rebreathing
Applicant	BPR MEDICAL, LTD. 22, HAMILTON WAY MANSFIELD, NOTTINGHAMSHIRE NG18 5BU GB Other 510(k) Applications for this Company
Contact	BEN JOHNSON Other 510(k) Applications for this Contact
Regulation Number	868.5870   More FDA Info for this Regulation Number
Classification Product Code	CBP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/15/2008
Decision Date	03/13/2009
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