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FDA 510(k)

PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE

K号: K171958 · 2018-01-12

决定日期2018-01-12
产品代码DZI
咨询委员会DE 请注意,您没有提供具体的医疗设备监管文本内容,因此我无法进行翻译。请提供需要翻译的具体文本,我将根据您的要求进行翻译。
决定实质等同

器械摘要

PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE is the device name listed in this FDA 510(k) record. The listed applicant is Mectron S.P.A.. It received FDA 510(k) clearance on 2018-01-12 under 510(k) number K171958. The device is classified under product code DZI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE?

PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE is a medical device that received FDA 510(k) clearance on 2018-01-12. The listed applicant is Mectron S.P.A.. The 510(k) number is K171958.

When did PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE receive FDA 510(k) clearance?

PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE received FDA 510(k) clearance on 2018-01-12, under 510(k) number K171958.

Who is the listed applicant for PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE?

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

What is the FDA product code for PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE?

The FDA product code for PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE is DZI.

相关临床试验

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。

列明Mectron S.P.A.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。

相关器械(代码:DZI)

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。

官方来源

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