NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar— 510(k) K212289
Substantially EquivalentNeuronetics, Inc.
FDA 510(k) clearance K212289 for NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar, Substantially Equivalent on 2022-05-06. Applicant: Neuronetics, Inc.. Device class: 2.
Clearance details
- Applicant
- Neuronetics, Inc.
- Product code
- Code QCI
- Device class
- Class 2
- Regulation
- 21 CFR 882.5802
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Malvern, PA, US
Recent devices under product code QCI
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
- K213543 — NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health
- K201158 — NeuroStar Advanced Therapy
Data sourced from openFDA. This site is unofficial and independent of the FDA.