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510(k) K234080

MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) by Soterix Medical, Inc. — Product Code GWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2024
Date Received
December 22, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Electrical, Evoked Response
Device Class
Class II
Regulation Number
882.1870
Review Panel
NE
Submission Type

Other clearances by Soterix Medical, Inc.

  • K251653 — SPRY TMS Therapy System (0550) (February 20, 2026)
  • K233751 — Milieve (YPS-301BD) (June 3, 2024)
  • K192823 — MEGA-TMS (August 13, 2021)
  • K191422 — Neural Navigator (April 6, 2020)
  • K170291 — IontoDC (May 1, 2017)

Other clearances for product code GWF

  • K252842 — SafeOp 3: Neural Informatix System (January 11, 2026)
  • K243982 — Nicolet EDX (January 22, 2025)
  • K243495 — Natus Ultrapro S100 (982A0594) (December 12, 2024)
  • K242345 — Delphi Stimulator (November 5, 2024)
  • K234092 — SafeOp 3: Neural Informatix Systeem (April 19, 2024)
  • K233292 — ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (October 27, 2023)
  • K230415 — Cadwell Guardian (August 17, 2023)
  • K213849 — SafeOp 2: Neural Informatix System (March 9, 2022)
  • K212166 — ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (January 7, 2022)
  • K192823 — MEGA-TMS (August 13, 2021)