Neuron-Spectrum-AM with Neuron-Spectrum.NET Software
FDA 510(k) K220254 · Neurosoft , Ltd.
510(k) numberK220254
Submission
- Device name
- Neuron-Spectrum-AM with Neuron-Spectrum.NET Software
- Applicant
- Neurosoft , Ltd.
Ivanovo, RU - Received
- January 31, 2022
- Decision date
- November 30, 2022
- 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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More from Kvikna Ehf
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|---|---|---|
| K190703 | Neuro-IOM system with Neuro-IOM.NET softwareGWF · Traditional | 05/22/2021SE |
| K133995 | NEURON-SPECTRUM-4/P with Neuron-Spectrum.Net SoftwareOLT · Traditional | 06/19/2015SE |
| K011241 | Neurosoft's SourceOLX · Traditional | 09/19/2001SE |
| K001781 | Curry Multimodal Neuroimaging SoftwareOLX · Traditional | 02/05/2001SE |
| K001692 | Neuro Scan Medical Ststems, Model Medicor 8JXE · Traditional | 11/24/2000SE |
| K000812 | Neuro Scan Medical Systems, Models 302L Medicor (Laboratory) and 302P Advantage 3000…IKN · Traditional | 05/17/2000SE |
Questions and answers
When was Neuron-Spectrum-AM with Neuron-Spectrum.NET Software cleared by the FDA?
Neuron-Spectrum-AM with Neuron-Spectrum.NET Software (K220254) received a 510(k) decision of Substantially Equivalent on November 30, 2022, 303 days after the submission was received.
What is the product code of K220254?
The FDA product code is OLT – Non-Normalizing Quantitative Electroencephalograph Software, a Class II (moderate risk) device regulated under 21 CFR 882.1400.