Ceramill A-Temp
K号: K191843 · 2019-10-04
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决定日期2019-10-04
产品代码EBG
咨询委员会DE
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决定实质等同
器械摘要
Ceramill A-Temp is the device name listed in this FDA 510(k) record. The listed applicant is Amann Girrbach AG. It received FDA 510(k) clearance on 2019-10-04 under 510(k) number K191843. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Ceramill A-Temp?
Ceramill A-Temp is a medical device that received FDA 510(k) clearance on 2019-10-04. The listed applicant is Amann Girrbach AG. The 510(k) number is K191843.
When did Ceramill A-Temp receive FDA 510(k) clearance?
Ceramill A-Temp received FDA 510(k) clearance on 2019-10-04, under 510(k) number K191843.
Who is the listed applicant for Ceramill A-Temp?
The FDA 510(k) record lists Amann Girrbach AG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Ceramill A-Temp?
The FDA product code for Ceramill A-Temp is EBG.
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。
列明Amann Girrbach AG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：EBG）
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。
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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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