FDA 510(k)

EPINAUT

K号: K173541 · 2018-08-24

决定日期2018-08-24

产品代码BSO

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决定实质等同

器械摘要

EPINAUT is the device name listed in this FDA 510(k) record. The listed applicant is Imedicom Co., Ltd.. It received FDA 510(k) clearance on 2018-08-24 under 510(k) number K173541. The device is classified under product code BSO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EPINAUT?

EPINAUT is a medical device that received FDA 510(k) clearance on 2018-08-24. The listed applicant is Imedicom Co., Ltd.. The 510(k) number is K173541.

When did EPINAUT receive FDA 510(k) clearance?

EPINAUT received FDA 510(k) clearance on 2018-08-24, under 510(k) number K173541.

Who is the listed applicant for EPINAUT?

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

What is the FDA product code for EPINAUT?

The FDA product code for EPINAUT is BSO.

列明Imedicom Co., Ltd.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。

K182287MEDINAUT Plus K153296MEDINAUT椎体成形术系统 K150915SPINAUT-P K151268SPINAUT-V, SPINAUT-S, SPINAUT-I K150789SPINAUT-E, SPINAUT-I

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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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官方来源

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