FDA 510(k) Application Details - K191365

Device Classification Name	Electrode, Ion Specific, Sodium   More FDA Info for this Device
510(K) Number	K191365
Device Name	Electrode, Ion Specific, Sodium
Applicant	Nova Biomedical Corporation 200 Prospect St. Waltham, MA 02454 US Other 510(k) Applications for this Company
Contact	Cesidio Tempesta 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	05/22/2019
Decision Date	07/19/2019
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