Home / 510(k) Clearances / K083242

510(k) K083242

NEUROSIGN AVALANCHE MOTOR NERVE MONITOR by The Magstim Company , Ltd. — Product Code ETN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2009
Date Received
November 3, 2008
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

Other clearances by The Magstim Company , Ltd.

  • K232235 — Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Hori (October 25, 2023)
  • K223154 — Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, H (March 16, 2023)
  • 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)

Other clearances for product code ETN

  • K253536 — Evala Nerve Stimulator (EPNR002) (February 27, 2026)
  • K251672 — NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal Tu (February 10, 2026)
  • K242852 — ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM (June 13, 2025)
  • K233001 — Bioscope Neuromonitor Device (December 13, 2024)
  • K241917 — EARP Nerve Cuff Electrode (July 31, 2024)
  • K232888 — Disposable Laryngeal Electrodes (December 21, 2023)
  • K230320 — NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotrache (October 26, 2023)
  • K230853 — EARP Nerve Cuff Electrode (October 6, 2023)
  • K231580 — NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) (August 30, 2023)
  • K223254 — C2 Xplore (January 27, 2023)