FDA 510(k)

NeuroStar 高级治疗系统（所有先前已批准的型号）

K号: K231926 · 2024-03-22

决定日期2024-03-22

产品代码OBP

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决定实质等同

器械摘要

NeuroStar Advanced Therapy System (All previously cleared models) is the device name listed in this FDA 510(k) record. The listed applicant is Neuronetics, Inc.. It received FDA 510(k) clearance on 2024-03-22 under 510(k) number K231926. 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 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. The listed applicant is Neuronetics, Inc.. The 510(k) number is K231926.

When did NeuroStar Advanced Therapy System (All previously cleared models) receive FDA 510(k) clearance?

NeuroStar Advanced Therapy System (All previously cleared models) received FDA 510(k) clearance on 2024-03-22, under 510(k) number K231926.

Who is the listed applicant for NeuroStar Advanced Therapy System (All previously cleared models)?

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 Advanced Therapy System (All previously cleared models)?

The FDA product code for NeuroStar Advanced Therapy System (All previously cleared models) is OBP.

列明Neuronetics, Inc.为申报人的其他记录

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