FDA 510(k) Application Details - K063443

Device Classification Name	Devices, Breath Trapping, Alcohol   More FDA Info for this Device
510(K) Number	K063443
Device Name	Devices, Breath Trapping, Alcohol
Applicant	DRAGER SAFETY 333 ALPINE STREET EMMAUS, PA 18049 US Other 510(k) Applications for this Company
Contact	EVE DAMIANO Other 510(k) Applications for this Contact
Regulation Number	862.3050   More FDA Info for this Regulation Number
Classification Product Code	DJZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/14/2006
Decision Date	03/11/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review