FDA 510(k)

TRAUS SIP20

K号: K201292 · 2021-02-11

决定日期2021-02-11

产品代码EBW

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决定实质等同

器械摘要

TRAUS SIP20 is the device name listed in this FDA 510(k) record. The listed applicant is Saeshin Precision Co., Ltd.. It received FDA 510(k) clearance on 2021-02-11 under 510(k) number K201292. The device is classified under product code EBW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the TRAUS SIP20?

TRAUS SIP20 is a medical device that received FDA 510(k) clearance on 2021-02-11. The listed applicant is Saeshin Precision Co., Ltd.. The 510(k) number is K201292.

When did TRAUS SIP20 receive FDA 510(k) clearance?

TRAUS SIP20 received FDA 510(k) clearance on 2021-02-11, under 510(k) number K201292.

Who is the listed applicant for TRAUS SIP20?

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

What is the FDA product code for TRAUS SIP20?

The FDA product code for TRAUS SIP20 is EBW.

列明Saeshin Precision 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。

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