Zmaxx T系列
K号: K161219 · 2017-01-26
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决定日期2017-01-26
产品代码EIH
咨询委员会DE
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器械摘要
Zmaxx T Series is the device name listed in this FDA 510(k) record. The listed applicant is Maxx Digm, Inc.. It received FDA 510(k) clearance on 2017-01-26 under 510(k) number K161219. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Zmaxx T Series?
Zmaxx T Series is a medical device that received FDA 510(k) clearance on 2017-01-26. The listed applicant is Maxx Digm, Inc.. The 510(k) number is K161219.
When did Zmaxx T Series receive FDA 510(k) clearance?
Zmaxx T Series received FDA 510(k) clearance on 2017-01-26, under 510(k) number K161219.
Who is the listed applicant for Zmaxx T Series?
The FDA 510(k) record lists Maxx Digm, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Zmaxx T Series?
The FDA product code for Zmaxx T Series is EIH.
相关临床试验
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相关器械（代码：EIH）
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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