FDA 510(k)

SpringTMS

K号: K162797 · 2017-06-26

决定日期2017-06-26

产品代码OKP

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决定实质等同

器械摘要

SpringTMS is the device name listed in this FDA 510(k) record. The listed applicant is Eneura, Inc.. It received FDA 510(k) clearance on 2017-06-26 under 510(k) number K162797. The device is classified under product code OKP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SpringTMS?

SpringTMS is a medical device that received FDA 510(k) clearance on 2017-06-26. The listed applicant is Eneura, Inc.. The 510(k) number is K162797.

When did SpringTMS receive FDA 510(k) clearance?

SpringTMS received FDA 510(k) clearance on 2017-06-26, under 510(k) number K162797.

Who is the listed applicant for SpringTMS?

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

What is the FDA product code for SpringTMS?

The FDA product code for SpringTMS is OKP.

列明Eneura, Inc.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。

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