OPTIMUS NEURO SYSTEM— 510(k) K141911

Substantially Equivalent

Osteonic Co., Ltd.

FDA 510(k) clearance K141911 for OPTIMUS NEURO SYSTEM, Substantially Equivalent on 2015-02-10. Applicant: Osteonic Co., Ltd..

Clearance details

Applicant: Osteonic Co., Ltd.
Product code: Code GWO
Advisory panel: Neurology
Date received: 2014-07-15
Decision date: 2015-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fullerton, CA, US

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Adverse events under product code GWO

product code GWO

Malfunction: 583
Total: 583

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.