DiscoverEEG System, Model DE-401— 510(k) K142834

Substantially Equivalent

Neurowave Systems, Inc.

FDA 510(k) clearance K142834 for DiscoverEEG System, Model DE-401, Substantially Equivalent on 2015-06-23. Applicant: Neurowave Systems, Inc..

Clearance details

Applicant: Neurowave Systems, Inc.
Product code: Code OLT
Advisory panel: Neurology
Date received: 2014-09-30
Decision date: 2015-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland Heights, OH, US

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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.