Toothsi，微笑矫正器
K号: K223338 · 2023-02-09
广告
决定日期2023-02-09
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
Toothsi, Smilealigners is the device name listed in this FDA 510(k) record. The listed applicant is Makeo Healthcare Technologies Private Limited. It received FDA 510(k) clearance on 2023-02-09 under 510(k) number K223338. 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 Toothsi, Smilealigners?
Toothsi, Smilealigners is a medical device that received FDA 510(k) clearance on 2023-02-09. The listed applicant is Makeo Healthcare Technologies Private Limited. The 510(k) number is K223338.
When did Toothsi, Smilealigners receive FDA 510(k) clearance?
Toothsi, Smilealigners received FDA 510(k) clearance on 2023-02-09, under 510(k) number K223338.
Who is the listed applicant for Toothsi, Smilealigners?
The FDA 510(k) record lists Makeo Healthcare Technologies Private Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Toothsi, Smilealigners?
The FDA product code for Toothsi, Smilealigners is NXC.
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。
相关器械（代码：NXC）
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
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