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510(k) K190703

Neuro-IOM system with Neuro-IOM.NET software by Neurosoft , Ltd. — Product Code GWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2021
Date Received
March 18, 2019
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 Neurosoft , Ltd.

  • K220254 — Neuron-Spectrum-AM with Neuron-Spectrum.NET Software (November 30, 2022)
  • K133995 — NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE (June 19, 2015)
  • K011241 — NEUROSOFT'S SOURCE (September 19, 2001)
  • K001781 — CURRY MULTIMODAL NEUROIMAGING SOFTWARE (February 5, 2001)
  • K001692 — NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8 (November 24, 2000)
  • K000812 — NEURO SCAN MEDICAL SYSTEMS, MODELS 302L MEDICOR (LABORATORY) AND 302P ADVANTAGE (May 17, 2000)

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