FDA 510(k)

Sonendo 填充材料 5C

K号: K211995 · 2021-08-27

决定日期2021-08-27

产品代码KIF

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决定实质等同

器械摘要

Sonendo Filling Material 5C is the device name listed in this FDA 510(k) record. The listed applicant is Sonendo, Inc.. It received FDA 510(k) clearance on 2021-08-27 under 510(k) number K211995. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Sonendo Filling Material 5C?

Sonendo Filling Material 5C is a medical device that received FDA 510(k) clearance on 2021-08-27. The listed applicant is Sonendo, Inc.. The 510(k) number is K211995.

When did Sonendo Filling Material 5C receive FDA 510(k) clearance?

Sonendo Filling Material 5C received FDA 510(k) clearance on 2021-08-27, under 510(k) number K211995.

Who is the listed applicant for Sonendo Filling Material 5C?

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 Filling Material 5C?

The FDA product code for Sonendo Filling Material 5C is KIF.

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。

K203302GentleWave X K190359Sonendo GentleWave 系统 K181922Sonendo 材料A K160905Sonendo GentleWave 系统 K153157Sonendo 温和波系统

官方来源

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