Home / 510(k) Clearances / K152984

510(k) K152984

Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes by Bio Protech, Inc. — Product Code IKT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2016
Date Received
October 9, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Needle, Diagnostic Electromyograph
Device Class
Class II
Regulation Number
890.1385
Review Panel
NE
Submission Type

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