FDA 510(k) Application Details - K160613

Device Classification Name	Devices, Breath Trapping, Alcohol   More FDA Info for this Device
510(K) Number	K160613
Device Name	Devices, Breath Trapping, Alcohol
Applicant	SOBERLINK HEALTHCARE LLC 16787 BEACH BLVD #211 HUNTINGTON BEACH, CA 92647 US Other 510(k) Applications for this Company
Contact	JENNA COSTA 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	03/03/2016
Decision Date	07/14/2016
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