FDA 510(k)

蓝色天空生物对齐器

K号: K180107 · 2018-02-09

决定日期2018-02-09

产品代码NXC

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

Blue Sky Bio Aligner is the device name listed in this FDA 510(k) record. The listed applicant is Blue Sky Bio, LLC. It received FDA 510(k) clearance on 2018-02-09 under 510(k) number K180107. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Blue Sky Bio Aligner?

Blue Sky Bio Aligner is a medical device that received FDA 510(k) clearance on 2018-02-09. The listed applicant is Blue Sky Bio, LLC. The 510(k) number is K180107.

When did Blue Sky Bio Aligner receive FDA 510(k) clearance?

Blue Sky Bio Aligner received FDA 510(k) clearance on 2018-02-09, under 510(k) number K180107.

Who is the listed applicant for Blue Sky Bio Aligner?

The FDA 510(k) record lists Blue Sky Bio, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Blue Sky Bio Aligner?

The FDA product code for Blue Sky Bio Aligner is NXC.

列明Blue Sky Bio, LLC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。

K232653Blue Sky Plan 软件，Blue Sky Bio Aligner Z 和 Blue Sky Bio Aligner Z FLX K221845蓝色天空生物对齐器G & 蓝天计划S/W，用于蓝色天空生物对齐器G K212785Blue Sky Bio 多功能植入系统，Blue Sky Bio 长期植入系统，Blue Sky Bio PEEK 临时基台 K202026蓝色天空生物CAD-CAM基座 K201919Blue Sky Bio TAD K190491Blue Sky Bio 颧骨植入系统

查看所有 8 个设备 →

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。