FDA 510(k)

GelPOINT Mini Advanced Access Platform

K号: K191866 · 2020-04-29

决定日期2020-04-29

产品代码GCJ

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决定实质等同

器械摘要

GelPOINT Mini Advanced Access Platform is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical. It received FDA 510(k) clearance on 2020-04-29 under 510(k) number K191866. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the GelPOINT Mini Advanced Access Platform?

GelPOINT Mini Advanced Access Platform is a medical device that received FDA 510(k) clearance on 2020-04-29. The listed applicant is Applied Medical. The 510(k) number is K191866.

When did GelPOINT Mini Advanced Access Platform receive FDA 510(k) clearance?

GelPOINT Mini Advanced Access Platform received FDA 510(k) clearance on 2020-04-29, under 510(k) number K191866.

Who is the listed applicant for GelPOINT Mini Advanced Access Platform?

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

What is the FDA product code for GelPOINT Mini Advanced Access Platform?

The FDA product code for GelPOINT Mini Advanced Access Platform is GCJ.

列明Applied Medical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：GCJ）

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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