CNS Envision
FDA 510(k) K192572 · Moberg Research, Inc.
510(k) numberK192572
Submission
- Device name
- CNS Envision
- Applicant
- Moberg Research, Inc.
Ambler, PA, US - Received
- September 18, 2019
- Decision date
- December 17, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OLT – Non-Normalizing Quantitative Electroencephalograph Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1400
- Specialty
- Neurology
Analyze electroencephalograph data using conventional methodology to output and display standard electroencephalograph parameters for interpretation by a qualified user.
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|---|---|---|---|
| K254213 | Pascall Sensor Unit (PSU1)OLT · Special | Pascall Systems, Inc. | 08/19/2026SE |
| K253767 | UB ERP SystemOLT · Traditional | Universal Brain | 06/30/2026SE |
| K251881 | HippoMind (v1.0)OLT · Traditional | Hippoclinic | 12/03/2025SE |
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| K220254 | Neuron-Spectrum-AM with Neuron-Spectrum.NET SoftwareOLT · Traditional | Neurosoft , Ltd. | 11/30/2022SE |
| K213299 | Wireless EEG SystemOLT · Traditional | Pascall Systems, Inc. | 05/11/2022SE |
| K191322 | E-Eegx, N-EegxOLT · Traditional | GE Healthcare Finland Oy | 01/22/2020SE |
| K190760 | Cadwell Bolt SoftwareOLT · Traditional | Cadwell Industries, Inc. | 11/23/2019SE |
| K143487 | Lifelines iEEGOLT · Traditional | Kvikna Ehf | 08/21/2015SE |
More from Kvikna Ehf
| 510(k) | Device | Decision |
|---|---|---|
| K080217 | Component Neuromonitoring SystemOMA · Traditional | 11/05/2008SE |
Questions and answers
When was CNS Envision cleared by the FDA?
CNS Envision (K192572) received a 510(k) decision of Substantially Equivalent on December 17, 2019, 90 days after the submission was received.
What is the product code of K192572?
The FDA product code is OLT – Non-Normalizing Quantitative Electroencephalograph Software, a Class II (moderate risk) device regulated under 21 CFR 882.1400.