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FDA 510(k)

Modular Toga

K号: K200977 · 2020-08-05

决定日期2020-08-05
产品代码FYA
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决定实质等同

器械摘要

Modular Toga is the device name listed in this FDA 510(k) record. The listed applicant is Operating Room Innovations, Inc.. It received FDA 510(k) clearance on 2020-08-05 under 510(k) number K200977. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Modular Toga?

Modular Toga is a medical device that received FDA 510(k) clearance on 2020-08-05. The listed applicant is Operating Room Innovations, Inc.. The 510(k) number is K200977.

When did Modular Toga receive FDA 510(k) clearance?

Modular Toga received FDA 510(k) clearance on 2020-08-05, under 510(k) number K200977.

Who is the listed applicant for Modular Toga?

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

What is the FDA product code for Modular Toga?

The FDA product code for Modular Toga is FYA.

相关临床试验

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相关器械(代码:FYA)

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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