NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health— 510(k) K213543

Substantially Equivalent

Neuronetics, Inc.

FDA 510(k) clearance K213543 for NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health, Substantially Equivalent on 2021-12-10. Applicant: Neuronetics, Inc..

Clearance details

Applicant: Neuronetics, Inc.
Product code: Code OBP
Advisory panel: Neurology
Date received: 2021-11-08
Decision date: 2021-12-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Malvern, PA, US

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Adverse events under product code OBP

product code OBP

Injury: 270
Total: 270

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.