FDA 510(k)

Sectra Digital Pathology Module

K号: K193054 · 2020-03-31

决定日期2020-03-31

产品代码QKQ

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决定实质等同

器械摘要

Sectra Digital Pathology Module is the device name listed in this FDA 510(k) record. The listed applicant is Sectra AB. It received FDA 510(k) clearance on 2020-03-31 under 510(k) number K193054. The device is classified under product code QKQ. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Sectra Digital Pathology Module?

Sectra Digital Pathology Module is a medical device that received FDA 510(k) clearance on 2020-03-31. The listed applicant is Sectra AB. The 510(k) number is K193054.

When did Sectra Digital Pathology Module receive FDA 510(k) clearance?

Sectra Digital Pathology Module received FDA 510(k) clearance on 2020-03-31, under 510(k) number K193054.

Who is the listed applicant for Sectra Digital Pathology Module?

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

What is the FDA product code for Sectra Digital Pathology Module?

The FDA product code for Sectra Digital Pathology Module is QKQ.

列明Sectra AB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。

K232208Sectra Digital Pathology Module (Version 3.3)

官方来源

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