510(k) K061107

DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247 by Thermo Electron OY — Product Code CEM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2006
Date Received
April 20, 2006
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