FDA 510(k)

SpringTMS

K号: K182976 · 2019-02-25

决定日期2019-02-25

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 2019-02-25 under 510(k) number K182976. 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 2019-02-25. The listed applicant is Eneura®, Inc.. The 510(k) number is K182976.

When did SpringTMS receive FDA 510(k) clearance?

SpringTMS received FDA 510(k) clearance on 2019-02-25, under 510(k) number K182976.

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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