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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Ion Specific, Potassium
510(k) Number K932044
Device Name DU PONT ISE SENSOR CARTRIDGE/REVISED TCO2 ELECTROD
Applicant
Dupont Medical Products
Bmp 22/1168
Wilmington,  DE  19880
Applicant Contact CAROLYN K GEORGE
Correspondent
Dupont Medical Products
Bmp 22/1168
Wilmington,  DE  19880
Correspondent Contact CAROLYN K GEORGE
Regulation Number862.1600
Classification Product Code
CEM  
Date Received04/27/1993
Decision Date 07/27/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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