FDA 510(k)

Sonendo GentleWave 系统

K号: K190359 · 2019-03-16

决定日期2019-03-16

产品代码ELC

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决定实质等同

器械摘要

Sonendo GentleWave System is the device name listed in this FDA 510(k) record. The listed applicant is Sonendo, Inc.. It received FDA 510(k) clearance on 2019-03-16 under 510(k) number K190359. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Sonendo GentleWave System?

Sonendo GentleWave System is a medical device that received FDA 510(k) clearance on 2019-03-16. The listed applicant is Sonendo, Inc.. The 510(k) number is K190359.

When did Sonendo GentleWave System receive FDA 510(k) clearance?

Sonendo GentleWave System received FDA 510(k) clearance on 2019-03-16, under 510(k) number K190359.

Who is the listed applicant for Sonendo GentleWave System?

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

What is the FDA product code for Sonendo GentleWave System?

The FDA product code for Sonendo GentleWave System is ELC.

列明Sonendo, 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。

K211995Sonendo 填充材料 5C K203302GentleWave X K181922Sonendo 材料A K160905Sonendo GentleWave 系统 K153157Sonendo 温和波系统

相关器械（代码：ELC）

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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