FDA 510(k)

Silk Voice

K号: K180631 · 2018-11-08

决定日期2018-11-08

产品代码MIX

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决定实质等同

器械摘要

Silk Voice is the device name listed in this FDA 510(k) record. The listed applicant is Sofregen Medical, Inc.. It received FDA 510(k) clearance on 2018-11-08 under 510(k) number K180631. The device is classified under product code MIX. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Silk Voice?

Silk Voice is a medical device that received FDA 510(k) clearance on 2018-11-08. The listed applicant is Sofregen Medical, Inc.. The 510(k) number is K180631.

When did Silk Voice receive FDA 510(k) clearance?

Silk Voice received FDA 510(k) clearance on 2018-11-08, under 510(k) number K180631.

Who is the listed applicant for Silk Voice?

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

What is the FDA product code for Silk Voice?

The FDA product code for Silk Voice is MIX.

列明Sofregen 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。

K172545SERI 外形

官方来源

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