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510(k) K141208

DYNAMIC NEUROSCREENING DEVICE by Prosenex — Product Code LQW

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 23, 2014
Date Received: May 9, 2014
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Test, Temperature Discrimination
Device Class: Class I
Regulation Number: 882.1200
Review Panel: NE
Submission Type