NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1— 510(k) K083538

Substantially Equivalent

Neuronetics

FDA 510(k) clearance K083538 for NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1, Substantially Equivalent on 2008-12-16. Applicant: Neuronetics.

Clearance details

Applicant: Neuronetics
Product code: Code OBP
Advisory panel: Neurology
Date received: 2008-11-28
Decision date: 2008-12-16
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.