FDA 510(k)

Ceramill A-Splint

K号: K191836 · 2019-12-20

决定日期2019-12-20

产品代码MQC

决定实质等同

器械摘要

Ceramill A-Splint is the device name listed in this FDA 510(k) record. The listed applicant is Amann Girrbach AG. It received FDA 510(k) clearance on 2019-12-20 under 510(k) number K191836. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

常见问题

What is the Ceramill A-Splint?

Ceramill A-Splint is a medical device that received FDA 510(k) clearance on 2019-12-20. The listed applicant is Amann Girrbach AG. The 510(k) number is K191836.

When did Ceramill A-Splint receive FDA 510(k) clearance?

Ceramill A-Splint received FDA 510(k) clearance on 2019-12-20, under 510(k) number K191836.

Who is the listed applicant for Ceramill A-Splint?

The FDA 510(k) record lists Amann Girrbach AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ceramill A-Splint?

The FDA product code for Ceramill A-Splint is MQC.

列明Amann Girrbach AG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。

K260918Zolid Lunaris K191843Ceramill A-Temp K171876Ceramill Zolid HT+ 白色

官方来源

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