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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 K844559
Device Name MODEL 1020 NA+/K+(SODIUM/POTASSIUM)ANALYZER MULTI
Applicant
Thermo Orion
840 Memorial Dr.
Cambridge,  MA  02139
Applicant Contact LYNN ORLOWITZ
Correspondent
Thermo Orion
840 Memorial Dr.
Cambridge,  MA  02139
Correspondent Contact LYNN ORLOWITZ
Regulation Number862.1665
Classification Product Code
JGS  
Date Received11/21/1984
Decision Date 01/18/1985
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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