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510(k) K133517

NEMUS 2 SYSTEM by Eb Neuro S.P.A. — Product Code GWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 2014
Date Received
November 15, 2013
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

Other clearances by Eb Neuro S.P.A.

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  • K150220 — STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast (August 19, 2015)
  • K142064 — GALILEO NT (February 13, 2015)
  • K121996 — BE PLUS LTM AMPLIFIER GWI AMPLIFIER (August 3, 2012)
  • K093728 — BE MICRO, TREA (April 29, 2010)
  • K073415 — NEMUS SYSTEM; NEMUS PC PERIPHERAL (May 23, 2008)
  • K061996 — SANDMAN POCKET (October 3, 2006)
  • K053606 — BE PLUS / AURA-LTM64 AMPLIFIER (January 24, 2006)
  • K041198 — NIC36 AMPLIFIER (June 1, 2004)

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)