FDA 510(k)

HAMILTON-MR1

K号: K153046 · 2016-09-06

决定日期2016-09-06

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-MR1 is the device name listed in this FDA 510(k) record. The listed applicant is Hamilton Medical AG. It received FDA 510(k) clearance on 2016-09-06 under 510(k) number K153046. 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-MR1?

HAMILTON-MR1 is a medical device that received FDA 510(k) clearance on 2016-09-06. The listed applicant is Hamilton Medical AG. The 510(k) number is K153046.

When did HAMILTON-MR1 receive FDA 510(k) clearance?

HAMILTON-MR1 received FDA 510(k) clearance on 2016-09-06, under 510(k) number K153046.

Who is the listed applicant for HAMILTON-MR1?

The FDA 510(k) record lists Hamilton Medical AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HAMILTON-MR1?

The FDA product code for HAMILTON-MR1 is CBK.

列明Hamilton Medical AG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。

K201306HAMILTON-C3 K201658Hamilton-C6 K193228Hamilton-G5 K181216HAMILTON-T1，HAMILTON-C1 K163283HAMILTON-H900，HAMILTON-BC8010，HAMILTON-BC4010 K161450HAMILTON-C3

查看所有 9 个设备 →

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

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