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510(k) K052060

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

K052060 is an FDA 510(k) premarket notification submitted by Intelligent Hearing Systems for the device "OPTI-AMP DC-POWERED". The FDA issued a decision of Substantially Equivalent on August 31, 2005. The device falls under product code GWL (Amplifier, Physiological Signal), a Class II device regulated under 21 CFR 882.1835. Intelligent Hearing Systems has at least 10 other 510(k) clearances on record.

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

Other clearances by Intelligent Hearing Systems

  • K163326 — SmartEP (September 29, 2017)
  • K090579 — SMARTSCREENER-PLUS2 (July 7, 2009)
  • K073384 — SMART COUPLER, MODEL M015401 (February 28, 2008)
  • K070608 — SMARTEP, MODEL M010000 (July 18, 2007)
  • K063402 — WICK ELECTRODE, MODEL M019260 (December 11, 2006)
  • 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)

Other clearances for product code GWL

  • K243746 — Delphi Amplifier (March 12, 2025)
  • K242832 — NExT Station; NExT Station Advanced (December 12, 2024)
  • K242305 — BE Plus PRO, Neurotravel LIGHT (September 4, 2024)
  • K240646 — DreamClear (September 4, 2024)
  • K232210 — X-trodes System M (February 4, 2024)
  • K230148 — Vlab (October 11, 2023)
  • K223676 — SomniCheck (June 1, 2023)
  • K220631 — NomadAir PMU810 (July 15, 2022)
  • K203331 — Quick-20m (May 20, 2021)
  • K202174 — Digital NeuroPort Biopotential Signal Processing System (February 10, 2021)

FDA data resources