FDA 510(k)

Viveve射频系统，安全

K号: K180584 · 2018-04-06

决定日期2018-04-06

产品代码GEI

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决定实质等同

器械摘要

Viveve RF System, Secure is the device name listed in this FDA 510(k) record. The listed applicant is Viveve, Inc.. It received FDA 510(k) clearance on 2018-04-06 under 510(k) number K180584. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Viveve RF System, Secure?

Viveve RF System, Secure is a medical device that received FDA 510(k) clearance on 2018-04-06. The listed applicant is Viveve, Inc.. The 510(k) number is K180584.

When did Viveve RF System, Secure receive FDA 510(k) clearance?

Viveve RF System, Secure received FDA 510(k) clearance on 2018-04-06, under 510(k) number K180584.

Who is the listed applicant for Viveve RF System, Secure?

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

What is the FDA product code for Viveve RF System, Secure?

The FDA product code for Viveve RF System, Secure is GEI.

列明Viveve, 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。

K213814Viveve 2.0 系统 K162547Viveve系统

相关器械（代码：GEI）

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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