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510(k) K220254

Device
Neuron-Spectrum-AM With Neuron-Spectrum.NET Software
Applicant
Neurosoft Ltd.
510(k) number
K220254
Product code
OLT  
Decision
Substantially Equivalent (SESE)
Decision date
2022-11-30
Date received
2022-01-31
Regulation
882.1400
Classification name
Non-normalizing Quantitative Electroencephalograph Software
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Michael Durdin
Address
5, Voronin St. Ivanovo RU 153032 153032

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

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FDA Review#

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