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510(k) K063402

WICK ELECTRODE, MODEL M019260 by Intelligent Hearing Systems — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2006
Date Received
November 9, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Cutaneous
Device Class
Class II
Regulation Number
882.1320
Review Panel
NE
Submission Type

Other clearances by Intelligent Hearing Systems

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  • K070608 — SMARTEP, MODEL M010000 (July 18, 2007)
  • K061443 — SMART USBLITE, MODEL M011120 (June 23, 2006)
  • K052060 — OPTI-AMP DC-POWERED (August 31, 2005)
  • K031051 — SMARTEP-ASSR, MODEL M811007 (February 20, 2004)
  • K023859 — SMARTTROAE (January 8, 2003)
  • K964426 — SMARTOAE (February 3, 1997)
  • K925648 — SMART-SCREENER (AUDITORY) (May 11, 1993)

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