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510(k) K052060

OPTI-AMP DC-POWERED by Intelligent Hearing Systems — Product Code GWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 2005
Date Received
July 29, 2005
Clearance Type
Special
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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  • K061443 — SMART USBLITE, MODEL M011120 (June 23, 2006)
  • 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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