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FDA 510(k)

伪患者

K号: K180697 · 2018-07-10

申请人Rtsafe, Inc.
决定日期2018-07-10
产品代码IYE
咨询委员会RA
决定实质等同

器械摘要

Pseudo-Patient is the device name listed in this FDA 510(k) record. The listed applicant is Rtsafe, Inc.. It received FDA 510(k) clearance on 2018-07-10 under 510(k) number K180697. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Pseudo-Patient?

Pseudo-Patient is a medical device that received FDA 510(k) clearance on 2018-07-10. The listed applicant is Rtsafe, Inc.. The 510(k) number is K180697.

When did Pseudo-Patient receive FDA 510(k) clearance?

Pseudo-Patient received FDA 510(k) clearance on 2018-07-10, under 510(k) number K180697.

Who is the listed applicant for Pseudo-Patient?

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

What is the FDA product code for Pseudo-Patient?

The FDA product code for Pseudo-Patient is IYE.

相关临床试验

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相关器械(代码:IYE)

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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