FDA 510(k)

HAMILTON-H900，HAMILTON-BC8010，HAMILTON-BC4010

K号: K163283 · 2017-09-20

决定日期2017-09-20

产品代码BTT

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决定实质等同

器械摘要

HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 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 2017-09-20 under 510(k) number K163283. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010?

HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 is a medical device that received FDA 510(k) clearance on 2017-09-20. The listed applicant is Hamilton Medical AG. The 510(k) number is K163283.

When did HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 receive FDA 510(k) clearance?

HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 received FDA 510(k) clearance on 2017-09-20, under 510(k) number K163283.

Who is the listed applicant for HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010?

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-H900, HAMILTON-BC8010, HAMILTON-BC4010?

The FDA product code for HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 is BTT.

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 K161450HAMILTON-C3 K153046HAMILTON-MR1

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相关器械（代码：BTT）

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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