Neuron-Spectrum-AM with Neuron-Spectrum.NET Software— 510(k) K220254

Substantially Equivalent

Neurosoft , Ltd.

FDA 510(k) clearance K220254 for Neuron-Spectrum-AM with Neuron-Spectrum.NET Software, Substantially Equivalent on 2022-11-30. Applicant: Neurosoft , Ltd..

Clearance details

Applicant: Neurosoft , Ltd.
Product code: Code OLT
Advisory panel: Neurology
Date received: 2022-01-31
Decision date: 2022-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ivanovo, RU

Download summary PDF View on FDA.gov ↗

Adverse events under product code OLT

product code OLT

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.