FDA 510(k)

GSI Corti

K号: K180287 · 2018-05-11

决定日期2018-05-11

产品代码EWO

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决定实质等同

器械摘要

GSI Corti is the device name listed in this FDA 510(k) record. The listed applicant is Grason-Stadler, Inc.. It received FDA 510(k) clearance on 2018-05-11 under 510(k) number K180287. The device is classified under product code EWO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the GSI Corti?

GSI Corti is a medical device that received FDA 510(k) clearance on 2018-05-11. The listed applicant is Grason-Stadler, Inc.. The 510(k) number is K180287.

When did GSI Corti receive FDA 510(k) clearance?

GSI Corti received FDA 510(k) clearance on 2018-05-11, under 510(k) number K180287.

Who is the listed applicant for GSI Corti?

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

What is the FDA product code for GSI Corti?

The FDA product code for GSI Corti is EWO.

列明Grason-Stadler, 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。

K172403GSI Novus

官方来源

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