NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE— 510(k) K133995

Substantially Equivalent

Neurosoft , Ltd.

FDA 510(k) clearance K133995 for NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE, Substantially Equivalent on 2015-06-19. Applicant: Neurosoft , Ltd..

Clearance details

Applicant: Neurosoft , Ltd.
Product code: Code OLT
Advisory panel: Neurology
Date received: 2013-12-26
Decision date: 2015-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abano Terme, Padova, IT

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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.