FDA 510(k) Application Details - K061597

Device Classification Name	Electrode, Ion Specific, Sodium   More FDA Info for this Device
510(K) Number	K061597
Device Name	Electrode, Ion Specific, Sodium
Applicant	EPOCAL, INC. 2935 CONROY ROAD OTTAWA K1G 6C6 CA Other 510(k) Applications for this Company
Contact	ROY LAYER 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	06/08/2006
Decision Date	09/27/2006
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