FDA 510(k) Application Details - K171476

Device Classification Name	Electrode, Ion Specific, Sodium   More FDA Info for this Device
510(K) Number	K171476
Device Name	Electrode, Ion Specific, Sodium
Applicant	Awareness Technology, Inc. 1935 S.W Martin Hwy. Palm City, FL 34990 US Other 510(k) Applications for this Company
Contact	Steve Andrus Other 510(k) Applications for this Contact
Regulation Number	862.1665   More FDA Info for this Regulation Number
Classification Product Code	JGS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/19/2017
Decision Date	02/27/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review