FDA 510(k) Application Details - K080278

Device Classification Name	Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase   More FDA Info for this Device
510(K) Number	K080278
Device Name	Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
Applicant	FIM MEDICAL PO BOX 7007 DEERFIELD, IL 60015 US Other 510(k) Applications for this Company
Contact	DANIEL KAMM 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	02/04/2008
Decision Date	11/28/2008
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