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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 K220396
Device Name EasyStat 300
Applicant
Medica Corporation
5 Oak Park Dr.
Bedford,  MA  01730
Applicant Contact Photios Makris
Correspondent
Medica Corporation
5 Oak Park Dr.
Bedford,  MA  01730
Correspondent Contact Photios Makris
Regulation Number862.1600
Classification Product Code
CEM  
Subsequent Product Codes
CGZ   JFP  
Date Received02/11/2022
Decision Date 09/26/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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