装甲LC
K号: K182118 · 2019-05-03
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决定日期2019-05-03
产品代码EIE
咨询委员会DE
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决定实质等同
器械摘要
armor LC is the device name listed in this FDA 510(k) record. The listed applicant is Mavrik Dental Systems, Ltd.. It received FDA 510(k) clearance on 2019-05-03 under 510(k) number K182118. The device is classified under product code EIE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the armor LC?
armor LC is a medical device that received FDA 510(k) clearance on 2019-05-03. The listed applicant is Mavrik Dental Systems, Ltd.. The 510(k) number is K182118.
When did armor LC receive FDA 510(k) clearance?
armor LC received FDA 510(k) clearance on 2019-05-03, under 510(k) number K182118.
Who is the listed applicant for armor LC?
The FDA 510(k) record lists Mavrik Dental Systems, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for armor LC?
The FDA product code for armor LC is EIE.
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：EIE）
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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