Honorst 嵌入系统
K号: K202039 · 2020-09-25
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决定日期2020-09-25
产品代码DZE
咨询委员会DE
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决定实质等同
器械摘要
Honorst Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Medimecca Co., Ltd.. It received FDA 510(k) clearance on 2020-09-25 under 510(k) number K202039. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Honorst Implant System?
Honorst Implant System is a medical device that received FDA 510(k) clearance on 2020-09-25. The listed applicant is Medimecca Co., Ltd.. The 510(k) number is K202039.
When did Honorst Implant System receive FDA 510(k) clearance?
Honorst Implant System received FDA 510(k) clearance on 2020-09-25, under 510(k) number K202039.
Who is the listed applicant for Honorst Implant System?
The FDA 510(k) record lists Medimecca Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Honorst Implant System?
The FDA product code for Honorst Implant System is DZE.
相关临床试验
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列明Medimecca Co., Ltd.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。
相关器械（代码：DZE）
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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