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FDA 510(k)

NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar

K-Number: K212289 · 2022-05-06

ApplicantNeuronetics, Inc.
Decision Date2022-05-06
Product CodeQCI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar is a medical device manufactured by Neuronetics, Inc.. It received FDA 510(k) clearance on 2022-05-06 under approval number K212289. The device is classified under product code QCI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar?

NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar is a medical device that received FDA 510(k) clearance on 2022-05-06. It is manufactured by Neuronetics, Inc.. The 510(k) number is K212289.

When was NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar approved by the FDA?

NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar received FDA 510(k) clearance on 2022-05-06, under approval number K212289.

What company makes NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar?

NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar is manufactured by Neuronetics, Inc..

What is the FDA product code for NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar?

The FDA product code for NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar is QCI.

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Related PubMed Literature

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Other Devices by Neuronetics, Inc.

K161519NeuroStar TMS Therapy System K160703NeuroStar TMS Therapy System K201158NeuroStar Advanced Therapy K213543NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health K222230NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health K220127NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health

View all 8 devices →

Related Devices (Code: QCI)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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