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FDA 510(k)

Midmark 额外口腔成像系统(EOIS)

K号: K201667 · 2020-08-06

决定日期2020-08-06
产品代码OAS
咨询委员会RA
决定实质等同

器械摘要

Midmark Extraoral Imaging System (EOIS) is the device name listed in this FDA 510(k) record. The listed applicant is Midmark Corporation. It received FDA 510(k) clearance on 2020-08-06 under 510(k) number K201667. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Midmark Extraoral Imaging System (EOIS)?

Midmark Extraoral Imaging System (EOIS) is a medical device that received FDA 510(k) clearance on 2020-08-06. The listed applicant is Midmark Corporation. The 510(k) number is K201667.

When did Midmark Extraoral Imaging System (EOIS) receive FDA 510(k) clearance?

Midmark Extraoral Imaging System (EOIS) received FDA 510(k) clearance on 2020-08-06, under 510(k) number K201667.

Who is the listed applicant for Midmark Extraoral Imaging System (EOIS)?

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

What is the FDA product code for Midmark Extraoral Imaging System (EOIS)?

The FDA product code for Midmark Extraoral Imaging System (EOIS) is OAS.

相关临床试验

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列明Midmark Corporation为申报人的其他记录

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相关器械(代码:OAS)

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。

官方来源

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