陶瓷托架正畸
K号: K222847 · 2023-05-04
广告
决定日期2023-05-04
产品代码NJM
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
Ceramic Brackets Orthometric is the device name listed in this FDA 510(k) record. The listed applicant is Orthometric - Industria E Comercio DE Produtos Medicos. It received FDA 510(k) clearance on 2023-05-04 under 510(k) number K222847. The device is classified under product code NJM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Ceramic Brackets Orthometric?
Ceramic Brackets Orthometric is a medical device that received FDA 510(k) clearance on 2023-05-04. The listed applicant is Orthometric - Industria E Comercio DE Produtos Medicos. The 510(k) number is K222847.
When did Ceramic Brackets Orthometric receive FDA 510(k) clearance?
Ceramic Brackets Orthometric received FDA 510(k) clearance on 2023-05-04, under 510(k) number K222847.
Who is the listed applicant for Ceramic Brackets Orthometric?
The FDA 510(k) record lists Orthometric - Industria E Comercio DE Produtos Medicos as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Ceramic Brackets Orthometric?
The FDA product code for Ceramic Brackets Orthometric is NJM.
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：NJM）
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