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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, Sodium
510(k) Number K873074
Device Name SODIUM AND POTASSIUM BY ION SELECTIVE
Applicant
American Monitor Corp.
P.O. Box 68505
Indianapolis,  IN  46268
Applicant Contact LUANN OCHS
Correspondent
American Monitor Corp.
P.O. Box 68505
Indianapolis,  IN  46268
Correspondent Contact LUANN OCHS
Regulation Number862.1665
Classification Product Code
JGS  
Date Received08/06/1987
Decision Date 10/20/1987
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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