FDA 510(k)

Vibe SF 自适应助听器

K号: K220403 · 2022-08-12

决定日期2022-08-12

产品代码QDD

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决定实质等同

器械摘要

Vibe SF Self-Fitting Hearing Aid is the device name listed in this FDA 510(k) record. The listed applicant is Wsaud A/S. It received FDA 510(k) clearance on 2022-08-12 under 510(k) number K220403. The device is classified under product code QDD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Vibe SF Self-Fitting Hearing Aid?

Vibe SF Self-Fitting Hearing Aid is a medical device that received FDA 510(k) clearance on 2022-08-12. The listed applicant is Wsaud A/S. The 510(k) number is K220403.

When did Vibe SF Self-Fitting Hearing Aid receive FDA 510(k) clearance?

Vibe SF Self-Fitting Hearing Aid received FDA 510(k) clearance on 2022-08-12, under 510(k) number K220403.

Who is the listed applicant for Vibe SF Self-Fitting Hearing Aid?

The FDA 510(k) record lists Wsaud A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vibe SF Self-Fitting Hearing Aid?

The FDA product code for Vibe SF Self-Fitting Hearing Aid is QDD.

列明Wsaud A/S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。

K233464WSA 自适应助听器第二代

官方来源

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