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FDA 510(k)

Riva Star

K号: K172047 · 2018-04-11

申请人Sdi Limited
决定日期2018-04-11
产品代码PHR
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决定实质等同

器械摘要

Riva Star is the device name listed in this FDA 510(k) record. The listed applicant is Sdi Limited. It received FDA 510(k) clearance on 2018-04-11 under 510(k) number K172047. The device is classified under product code PHR. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Riva Star?

Riva Star is a medical device that received FDA 510(k) clearance on 2018-04-11. The listed applicant is Sdi Limited. The 510(k) number is K172047.

When did Riva Star receive FDA 510(k) clearance?

Riva Star received FDA 510(k) clearance on 2018-04-11, under 510(k) number K172047.

Who is the listed applicant for Riva Star?

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

What is the FDA product code for Riva Star?

The FDA product code for Riva Star is PHR.

列明Sdi Limited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。

相关器械(代码:PHR)

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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数据来源于FDA开放API。如需最新且权威的信息,请务必参考官方记录。

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