FDA 510(k)

Operio

K号: K153498 · 2016-07-20

决定日期2016-07-20

产品代码ORC

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决定实质等同

器械摘要

Operio is the device name listed in this FDA 510(k) record. The listed applicant is Toul Meditech AB. It received FDA 510(k) clearance on 2016-07-20 under 510(k) number K153498. The device is classified under product code ORC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Operio?

Operio is a medical device that received FDA 510(k) clearance on 2016-07-20. The listed applicant is Toul Meditech AB. The 510(k) number is K153498.

When did Operio receive FDA 510(k) clearance?

Operio received FDA 510(k) clearance on 2016-07-20, under 510(k) number K153498.

Who is the listed applicant for Operio?

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

What is the FDA product code for Operio?

The FDA product code for Operio is ORC.

列明Toul Meditech 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。

K190027SteriStay K173349Operio

官方来源

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