FDA 510(k)

应用医疗内窥镜

K号: K200021 · 2021-01-06

决定日期2021-01-06

产品代码FER

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决定实质等同

器械摘要

Applied Medical Anoscope is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources. It received FDA 510(k) clearance on 2021-01-06 under 510(k) number K200021. The device is classified under product code FER. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Applied Medical Anoscope?

Applied Medical Anoscope is a medical device that received FDA 510(k) clearance on 2021-01-06. The listed applicant is Applied Medical Resources. The 510(k) number is K200021.

When did Applied Medical Anoscope receive FDA 510(k) clearance?

Applied Medical Anoscope received FDA 510(k) clearance on 2021-01-06, under 510(k) number K200021.

Who is the listed applicant for Applied Medical Anoscope?

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

What is the FDA product code for Applied Medical Anoscope?

The FDA product code for Applied Medical Anoscope is FER.

列明Applied Medical Resources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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官方来源

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