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510(k) K041908

CONTACT HEAT-EVOKED POTENTIAL STIMULATOR (CHEPS) by Medoc Ltd. Advanced Medical Systems — Product Code NTU

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 25, 2005
Date Received: July 15, 2004
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Evoked Potential Stimulator, Thermal
Device Class: Class II
Regulation Number: 882.1870
Review Panel: NE
Submission Type

Intended to evaluate the functionality of human pain reception and transmission of sensory pathways