510(k) K890792

POTASSIUM AND SODIUM ELECTROLYTE ANALYZER by Ionetics, Inc. — Product Code CEM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1989
Date Received
February 17, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion Specific, Potassium
Device Class
Class II
Regulation Number
862.1600
Review Panel
CH
Submission Type