NEUROSTAR TMS SYSTEM— 510(k) DEN070003

Unknown

Neuronetics

FDA 510(k) clearance DEN070003 for NEUROSTAR TMS SYSTEM, Unknown on 2008-10-07. Applicant: Neuronetics.

Clearance details

Applicant: Neuronetics
Product code: Code OBP
Advisory panel: Neurology
Date received: 2007-05-24
Decision date: 2008-10-07
Decision: Unknown
Clearance type: Post-NSE
Location: Malvern, PA, US

View on FDA.gov ↗

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.