FDA 510(k)

IntelliCuff

K号: K150893 · 2016-01-29

决定日期2016-01-29

产品代码BSK

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决定实质等同

器械摘要

IntelliCuff 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 2016-01-29 under 510(k) number K150893. The device is classified under product code BSK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the IntelliCuff?

IntelliCuff is a medical device that received FDA 510(k) clearance on 2016-01-29. The listed applicant is Hamilton Medical AG. The 510(k) number is K150893.

When did IntelliCuff receive FDA 510(k) clearance?

IntelliCuff received FDA 510(k) clearance on 2016-01-29, under 510(k) number K150893.

Who is the listed applicant for IntelliCuff?

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 IntelliCuff?

The FDA product code for IntelliCuff is BSK.

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

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官方来源

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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。