FDA 510(k)

Rodo Smilekey

K号: K180609 · 2018-05-23

决定日期2018-05-23

产品代码NHA

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决定实质等同

器械摘要

Rodo Smilekey is the device name listed in this FDA 510(k) record. The listed applicant is Rodo Medical, Inc.. It received FDA 510(k) clearance on 2018-05-23 under 510(k) number K180609. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Rodo Smilekey?

Rodo Smilekey is a medical device that received FDA 510(k) clearance on 2018-05-23. The listed applicant is Rodo Medical, Inc.. The 510(k) number is K180609.

When did Rodo Smilekey receive FDA 510(k) clearance?

Rodo Smilekey received FDA 510(k) clearance on 2018-05-23, under 510(k) number K180609.

Who is the listed applicant for Rodo Smilekey?

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

What is the FDA product code for Rodo Smilekey?

The FDA product code for Rodo Smilekey is NHA.

列明Rodo Medical, Inc.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。

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相关器械（代码：NHA）

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。

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