FDA 510(k) Application Details - K092686

Device Classification Name	Electrode, Ion Specific, Potassium   More FDA Info for this Device
510(K) Number	K092686
Device Name	Electrode, Ion Specific, Potassium
Applicant	RADIOMETER MEDICAL APS AKANDEVEJ 21 BRONSHOJ DK-2700 DK Other 510(k) Applications for this Company
Contact	LONE RONNEMOES PEDERSEN Other 510(k) Applications for this Contact
Regulation Number	862.1600   More FDA Info for this Regulation Number
Classification Product Code	CEM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/02/2009
Decision Date	08/06/2010
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