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510(k) K914876

OPTI-AMP by Intelligent Hearing Systems — Product Code GWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1992
Date Received
October 29, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Amplifier, Physiological Signal
Device Class
Class II
Regulation Number
882.1835
Review Panel
NE
Submission Type

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  • K063402 — WICK ELECTRODE, MODEL M019260 (December 11, 2006)
  • 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)

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