Hamilton-G5
K号: K180295 · 2019-07-30
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决定日期2019-07-30
产品代码CBK
咨询委员会AN
请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。
决定实质等同
器械摘要
Hamilton-G5 is the device name listed in this FDA 510(k) record. The listed applicant is Hamiton Medical AG. It received FDA 510(k) clearance on 2019-07-30 under 510(k) number K180295. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Hamilton-G5?
Hamilton-G5 is a medical device that received FDA 510(k) clearance on 2019-07-30. The listed applicant is Hamiton Medical AG. The 510(k) number is K180295.
When did Hamilton-G5 receive FDA 510(k) clearance?
Hamilton-G5 received FDA 510(k) clearance on 2019-07-30, under 510(k) number K180295.
Who is the listed applicant for Hamilton-G5?
The FDA 510(k) record lists Hamiton Medical AG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Hamilton-G5?
The FDA product code for Hamilton-G5 is CBK.
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：CBK）
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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