Maxima 电动系统
K号: K180845 · 2019-07-25
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决定日期2019-07-25
产品代码EBW
咨询委员会DE
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决定实质等同
器械摘要
Maxima Electric System is the device name listed in this FDA 510(k) record. The listed applicant is Handpiece Headquarters - Hpr, Inc.. It received FDA 510(k) clearance on 2019-07-25 under 510(k) number K180845. The device is classified under product code EBW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Maxima Electric System?
Maxima Electric System is a medical device that received FDA 510(k) clearance on 2019-07-25. The listed applicant is Handpiece Headquarters - Hpr, Inc.. The 510(k) number is K180845.
When did Maxima Electric System receive FDA 510(k) clearance?
Maxima Electric System received FDA 510(k) clearance on 2019-07-25, under 510(k) number K180845.
Who is the listed applicant for Maxima Electric System?
The FDA 510(k) record lists Handpiece Headquarters - Hpr, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Maxima Electric System?
The FDA product code for Maxima Electric System is EBW.
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：EBW）
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
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