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510(k) K192572

CNS Envision by Moberg Research, Inc. — Product Code OLT

K192572 is an FDA 510(k) premarket notification submitted by Moberg Research, Inc. for the device "CNS Envision". The FDA issued a decision of Substantially Equivalent on December 17, 2019. The device falls under product code OLT (Non-Normalizing Quantitative Electroencephalograph Software), a Class II device regulated under 21 CFR 882.1400. Moberg Research, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2019
Date Received
September 18, 2019
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 by Moberg Research, Inc.

  • K080217 — COMPONENT NEUROMONITORING SYSTEM (November 5, 2008)

Other clearances for product code OLT

  • K253767 — UB ERP System (June 30, 2026)
  • 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)
  • 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)
  • 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