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510(k) K240593

VEEGix EEG System by NeuroServo, Inc. — Product Code OLT

K240593 is an FDA 510(k) premarket notification submitted by NeuroServo, Inc. for the device "VEEGix EEG System". The FDA issued a decision of Substantially Equivalent on August 23, 2024. The device falls under product code OLT (Non-Normalizing Quantitative Electroencephalograph Software), a Class II device regulated under 21 CFR 882.1400.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 2024
Date Received
March 1, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Non-Normalizing Quantitative Electroencephalograph Software
Device Class
Class II
Regulation Number
882.1400
Review Panel
NE
Submission Type

Analyze electroencephalograph data using conventional methodology to output and display standard electroencephalograph parameters for interpretation by a qualified user.

Other clearances for product code OLT

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  • K251881 — HippoMind (v1.0) (December 3, 2025)
  • K251366 — EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS- (October 9, 2025)
  • K220254 — Neuron-Spectrum-AM with Neuron-Spectrum.NET Software (November 30, 2022)
  • K213299 — Wireless EEG System (May 11, 2022)
  • K191322 — E-EEGX, N-EEGX (January 22, 2020)
  • K192572 — CNS Envision (December 17, 2019)
  • K190760 — Cadwell Bolt Software (November 23, 2019)
  • K143487 — Lifelines iEEG (August 21, 2015)
  • K142834 — DiscoverEEG System, Model DE-401 (June 23, 2015)

FDA data resources