FDA 510(k)

Blue Sky Plan 软件，Blue Sky Bio Aligner Z 和 Blue Sky Bio Aligner Z FLX

K号: K232653 · 2024-04-03

决定日期2024-04-03

产品代码NXC

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决定实质等同

器械摘要

Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX 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 2024-04-03 under 510(k) number K232653. 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 Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX?

Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX is a medical device that received FDA 510(k) clearance on 2024-04-03. The listed applicant is Blue Sky Bio, LLC. The 510(k) number is K232653.

When did Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX receive FDA 510(k) clearance?

Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX received FDA 510(k) clearance on 2024-04-03, under 510(k) number K232653.

Who is the listed applicant for Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX?

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 Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX?

The FDA product code for Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX 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。

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 K180107蓝色天空生物对齐器

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官方来源

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