FDA 510(k) Application Details - K082315

Device Classification Name	Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase   More FDA Info for this Device
510(K) Number	K082315
Device Name	Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
Applicant	BEDFONT SCIENTIFIC LTD. 105 LAKER RD. ROCHESTER, KENT ME1 3QX GB Other 510(k) Applications for this Company
Contact	GLEN HILLSLEY Other 510(k) Applications for this Contact
Regulation Number	868.1430   More FDA Info for this Regulation Number
Classification Product Code	CCJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/13/2008
Decision Date	02/01/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review