FDA 510(k)

Neurosoft TMS（也称为CloudTMS）

K号: K173441 · 2017-12-13

决定日期2017-12-13

产品代码OBP

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决定实质等同

器械摘要

Neurosoft TMS (also CloudTMS) is the device name listed in this FDA 510(k) record. The listed applicant is Teleemg, LLC. It received FDA 510(k) clearance on 2017-12-13 under 510(k) number K173441. 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 Neurosoft TMS (also CloudTMS)?

Neurosoft TMS (also CloudTMS) is a medical device that received FDA 510(k) clearance on 2017-12-13. The listed applicant is Teleemg, LLC. The 510(k) number is K173441.

When did Neurosoft TMS (also CloudTMS) receive FDA 510(k) clearance?

Neurosoft TMS (also CloudTMS) received FDA 510(k) clearance on 2017-12-13, under 510(k) number K173441.

Who is the listed applicant for Neurosoft TMS (also CloudTMS)?

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

What is the FDA product code for Neurosoft TMS (also CloudTMS)?

The FDA product code for Neurosoft TMS (also CloudTMS) is OBP.

列明Teleemg, LLC为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K250689CloudTMS Edge K233742CloudTMS Edge 用于强迫症 K221129CloudTMS 用于强迫症 K160309Neurosoft TMS

官方来源

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