FDA 510(k) Application Details - K962334

Device Classification Name	Electrode, Ion Specific, Sodium   More FDA Info for this Device
510(K) Number	K962334
Device Name	Electrode, Ion Specific, Sodium
Applicant	RADIOMETER AMERICA, INC. 810 SHARON DR. WESTLAKE, OH 44145-1598 US Other 510(k) Applications for this Company
Contact	DONALD L BAKER 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	06/17/1996
Decision Date	10/24/1996
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