NeuroStar TMS Therapy System— 510(k) K161519
Substantially EquivalentNeuronetics, Inc.
FDA 510(k) clearance K161519 for NeuroStar TMS Therapy System, Substantially Equivalent on 2016-09-11. Applicant: Neuronetics, Inc.. Device class: 2.
Clearance details
- Applicant
- Neuronetics, Inc.
- Product code
- Code OBP
- Device class
- Class 2
- Regulation
- 21 CFR 882.5805
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Malvern, PA, US
Recent devices under product code OBP
view allMore clearances from Neuronetics, Inc.
view all- K231926 — NeuroStar Advanced Therapy System (All previously cleared models)
- K222230 — NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health
- K220127 — NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health
- K212289 — NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar
- K213543 — NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health
Adverse events under product code OBP
product code OBP- Injury
- 270
- Total
- 270
Source: openFDA MAUDE database, through . 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.