我的QA iON
K号: K201798 · 2020-07-17
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器械摘要
myQA iON is the device name listed in this FDA 510(k) record. The listed applicant is Iba Dosimetry GmbH. It received FDA 510(k) clearance on 2020-07-17 under 510(k) number K201798. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the myQA iON?
myQA iON is a medical device that received FDA 510(k) clearance on 2020-07-17. The listed applicant is Iba Dosimetry GmbH. The 510(k) number is K201798.
When did myQA iON receive FDA 510(k) clearance?
myQA iON received FDA 510(k) clearance on 2020-07-17, under 510(k) number K201798.
Who is the listed applicant for myQA iON?
The FDA 510(k) record lists Iba Dosimetry GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for myQA iON?
The FDA product code for myQA iON is LHN.
列明Iba Dosimetry GmbH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:LHN)
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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