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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 K901039
Device Name IONOMETER EH
Applicant
FRESENIUS USA, INC.
4090 PIKE LN.
CONCORD,  CA  94520
Applicant Contact THOMAS E CANE
Correspondent
FRESENIUS USA, INC.
4090 PIKE LN.
CONCORD,  CA  94520
Correspondent Contact THOMAS E CANE
Regulation Number862.1600
Classification Product Code
CEM  
Date Received03/06/1990
Decision Date 06/28/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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