FDA 510(k) Application Details - K123470

Device Classification Name	Devices, Breath Trapping, Alcohol   More FDA Info for this Device
510(K) Number	K123470
Device Name	Devices, Breath Trapping, Alcohol
Applicant	PAS SYSTEMS INTERNATIONAL, INC. 1616 PRINCESS ANNE STREET FREDERICKSBURG, VA 22401 US Other 510(k) Applications for this Company
Contact	JAREL R KELSEY 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	11/13/2012
Decision Date	04/29/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review