NeuroStar Advanced Therapy System (All previously cleared models)
K-Number: K231926 · 2024-03-22
ApplicantNeuronetics, Inc.
Decision Date2024-03-22
Product CodeOBP
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
NeuroStar Advanced Therapy System (All previously cleared models) is a medical device manufactured by Neuronetics, Inc.. It received FDA 510(k) clearance on 2024-03-22 under approval number K231926. The device is classified under product code OBP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the NeuroStar Advanced Therapy System (All previously cleared models)?
NeuroStar Advanced Therapy System (All previously cleared models) is a medical device that received FDA 510(k) clearance on 2024-03-22. It is manufactured by Neuronetics, Inc.. The 510(k) number is K231926.
When was NeuroStar Advanced Therapy System (All previously cleared models) approved by the FDA?
NeuroStar Advanced Therapy System (All previously cleared models) received FDA 510(k) clearance on 2024-03-22, under approval number K231926.
What company makes NeuroStar Advanced Therapy System (All previously cleared models)?
NeuroStar Advanced Therapy System (All previously cleared models) is manufactured by Neuronetics, Inc..
What is the FDA product code for NeuroStar Advanced Therapy System (All previously cleared models)?
The FDA product code for NeuroStar Advanced Therapy System (All previously cleared models) is OBP.
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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
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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.