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510(k) K071349

NEUROSIGN LARYNGEAL ELECTRODES by The Magstim Company , Ltd. — Product Code ETN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2007
Date Received
May 14, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve
Device Class
Class II
Regulation Number
874.1820
Review Panel
EN
Submission Type

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  • K222171 — Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, H (January 13, 2023)
  • K211389 — Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon (September 14, 2021)
  • K203684 — Neurosign V4 Intraoperative Nerve Monitor (March 17, 2021)
  • K183376 — HORIZON TMS Therapy System with Navigation (April 3, 2019)
  • K182853 — HORIZON TMS Therapy System (March 15, 2019)
  • K181559 — Neurosign V4 Intraoperative Nerve Monitor (November 9, 2018)
  • K180907 — HORIZON TMS Therapy System (August 3, 2018)
  • K171051 — HORIZON Therapy System (September 13, 2017)

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