FDA 510(k)

Ziehm Vision RFD 3D

K号: K243303 · 2025-01-21

决定日期2025-01-21

产品代码OWB

咨询委员会RA

决定实质等同

器械摘要

Ziehm Vision RFD 3D 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 2025-01-21 under 510(k) number K243303. 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 Vision RFD 3D?

Ziehm Vision RFD 3D is a medical device that received FDA 510(k) clearance on 2025-01-21. The listed applicant is Ziehm Imaging GmbH. The 510(k) number is K243303.

When did Ziehm Vision RFD 3D receive FDA 510(k) clearance?

Ziehm Vision RFD 3D received FDA 510(k) clearance on 2025-01-21, under 510(k) number K243303.

Who is the listed applicant for Ziehm Vision RFD 3D?

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 Vision RFD 3D?

The FDA product code for Ziehm Vision RFD 3D 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 K243328Ziehm视界RFD K240099Ziehm视界RFD K240020Ziehm Vision FD K234109齐姆索洛FD

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