FDA 510(k)

齐姆索洛FD

K号: K161976 · 2016-10-06

决定日期2016-10-06

产品代码OWB

咨询委员会RA

决定实质等同

器械摘要

Ziehm Solo FD is the device name listed in this FDA 510(k) record. The listed applicant is Ziehm Imaging GmbH. It received FDA 510(k) clearance on 2016-10-06 under 510(k) number K161976. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Ziehm Solo FD?

Ziehm Solo FD is a medical device that received FDA 510(k) clearance on 2016-10-06. The listed applicant is Ziehm Imaging GmbH. The 510(k) number is K161976.

When did Ziehm Solo FD receive FDA 510(k) clearance?

Ziehm Solo FD received FDA 510(k) clearance on 2016-10-06, under 510(k) number K161976.

Who is the listed applicant for Ziehm Solo FD?

The FDA 510(k) record lists Ziehm Imaging GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ziehm Solo FD?

The FDA product code for Ziehm Solo FD is OWB.

列明Ziehm Imaging 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。

K243646齐姆索洛FD K243735Ziehm Vision FD K243303Ziehm Vision RFD 3D K243328Ziehm视界RFD K240099Ziehm视界RFD K240020Ziehm Vision FD

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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。