Piezosurgery 白色
K号: K171326 · 2018-04-13
广告
决定日期2018-04-13
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 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 2018-04-13 under 510(k) number K171326. 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 White?
Piezosurgery White is a medical device that received FDA 510(k) clearance on 2018-04-13. The listed applicant is Mectron S.P.A.. The 510(k) number is K171326.
When did Piezosurgery White receive FDA 510(k) clearance?
Piezosurgery White received FDA 510(k) clearance on 2018-04-13, under 510(k) number K171326.
Who is the listed applicant for 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 White?
The FDA product code for 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。
K253655斜角螺丝刀 MED（M-SD090）W&H Dentalwerk Bürmoos GmbHK253776Implantmed Plus II & Piezomed Plus II 模块W&H Dentalwerk Buermoos GmbHK254163VarioSurg 4Nakanishi, Inc.K242432MT-BoneMectron S.P.A.K240340Surgical Drive System (型号：ES70，ES90，E8)Guangdong Jinme Medical Technology Co., Ltd.K231087引导手术套件Implant Direct Sybron Manufacturing, LLC
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
广告