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510(k) K253767

UB ERP System by Universal Brain — Product Code OLT

K253767 is an FDA 510(k) premarket notification submitted by Universal Brain for the device "UB ERP System". The FDA issued a decision of Substantially Equivalent on June 30, 2026. 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
June 30, 2026
Date Received
November 25, 2025
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.

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  • K240593 — VEEGix EEG System (August 23, 2024)
  • 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