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510(k) K242832

NExT Station; NExT Station Advanced by Eb Neuro S.P.A. — Product Code GWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2024
Date Received
September 19, 2024
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 Eb Neuro S.P.A.

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  • K142064 — GALILEO NT (February 13, 2015)
  • K133517 — NEMUS 2 SYSTEM (February 26, 2014)
  • 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)
  • K240646 — DreamClear (September 4, 2024)
  • K242305 — BE Plus PRO, Neurotravel LIGHT (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)
  • K201747 — 8-CH Electroencephalography Amplifier (December 27, 2020)