FDA 510(k)

NeuroStar TMS 治疗系统，NeuroStar 高级治疗系统，NeuroStar，NeuroStar 高级治疗用于心理健康

K号: K213543 · 2021-12-10

决定日期2021-12-10

产品代码OBP

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决定实质等同

器械摘要

NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health is the device name listed in this FDA 510(k) record. The listed applicant is Neuronetics, Inc.. It received FDA 510(k) clearance on 2021-12-10 under 510(k) number K213543. The device is classified under product code OBP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health?

NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health is a medical device that received FDA 510(k) clearance on 2021-12-10. The listed applicant is Neuronetics, Inc.. The 510(k) number is K213543.

When did NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health receive FDA 510(k) clearance?

NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health received FDA 510(k) clearance on 2021-12-10, under 510(k) number K213543.

Who is the listed applicant for NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health?

The FDA 510(k) record lists Neuronetics, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health is OBP.

列明Neuronetics, Inc.为申报人的其他记录

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