FDA 510(k)

Endo智能帽

K号: K223040 · 2023-03-01

决定日期2023-03-01

产品代码FAJ

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决定实质等同

器械摘要

Endo SmartCap is the device name listed in this FDA 510(k) record. The listed applicant is Medivators, Inc.. It received FDA 510(k) clearance on 2023-03-01 under 510(k) number K223040. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Endo SmartCap?

Endo SmartCap is a medical device that received FDA 510(k) clearance on 2023-03-01. The listed applicant is Medivators, Inc.. The 510(k) number is K223040.

When did Endo SmartCap receive FDA 510(k) clearance?

Endo SmartCap received FDA 510(k) clearance on 2023-03-01, under 510(k) number K223040.

Who is the listed applicant for Endo SmartCap?

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

What is the FDA product code for Endo SmartCap?

The FDA product code for Endo SmartCap is FAJ.

列明Medivators, 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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相关器械（代码：FAJ）

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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