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510(k) K191322

E-EEGX, N-EEGX by GE Healthcare Finland Oy — Product Code OLT

K191322 is an FDA 510(k) premarket notification submitted by GE Healthcare Finland Oy for the device "E-EEGX, N-EEGX". The FDA issued a decision of Substantially Equivalent on January 22, 2020. The device falls under product code OLT (Non-Normalizing Quantitative Electroencephalograph Software), a Class II device regulated under 21 CFR 882.1400. GE Healthcare Finland Oy has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2020
Date Received
May 15, 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 GE Healthcare Finland Oy

  • K223531 — CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 (April 6, 2023)
  • K213363 — CARESCAPE B450, E-musb (April 13, 2022)
  • K213336 — Carescape B850, E-musb (April 13, 2022)
  • K213181 — CARESCAPE B650, E-musb (April 13, 2022)
  • K211171 — CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiO (October 21, 2021)
  • K191323 — Carescape B850 (January 29, 2020)
  • K191249 — CARESCAPE B450 (January 24, 2020)
  • K191149 — CARESCAPE B650 (January 21, 2020)
  • K183394 — CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO (May 1, 2019)
  • K171028 — CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAi (August 17, 2017)

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)
  • 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