coDiagnostiX
K号: K193301 · 2021-06-21
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决定日期2021-06-21
产品代码DZJ
咨询委员会DE
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决定实质等同
器械摘要
coDiagnostiX is the device name listed in this FDA 510(k) record. The listed applicant is Dental Wings GmbH. It received FDA 510(k) clearance on 2021-06-21 under 510(k) number K193301. The device is classified under product code DZJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the coDiagnostiX?
coDiagnostiX is a medical device that received FDA 510(k) clearance on 2021-06-21. The listed applicant is Dental Wings GmbH. The 510(k) number is K193301.
When did coDiagnostiX receive FDA 510(k) clearance?
coDiagnostiX received FDA 510(k) clearance on 2021-06-21, under 510(k) number K193301.
Who is the listed applicant for coDiagnostiX?
The FDA 510(k) record lists Dental Wings GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for coDiagnostiX?
The FDA product code for coDiagnostiX is DZJ.
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：DZJ）
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。
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