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510(k) K213299

Wireless EEG System by Pascall Systems, Inc. — Product Code OLT

K213299 is an FDA 510(k) premarket notification submitted by Pascall Systems, Inc. for the device "Wireless EEG System". The FDA issued a decision of Substantially Equivalent on May 11, 2022. 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
May 11, 2022
Date Received
October 1, 2021
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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  • K240593 — VEEGix EEG System (August 23, 2024)
  • K220254 — Neuron-Spectrum-AM with Neuron-Spectrum.NET Software (November 30, 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