FDA 510(k)

Ortho Device, ADAPTIX 3D Orthopedic Imaging System

K号: K221949 · 2023-01-26

决定日期2023-01-26

产品代码IZF

咨询委员会RA

决定实质等同

器械摘要

Ortho Device, ADAPTIX 3D Orthopedic Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Pausch Medical GmbH. It received FDA 510(k) clearance on 2023-01-26 under 510(k) number K221949. The device is classified under product code IZF. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Ortho Device, ADAPTIX 3D Orthopedic Imaging System?

Ortho Device, ADAPTIX 3D Orthopedic Imaging System is a medical device that received FDA 510(k) clearance on 2023-01-26. The listed applicant is Pausch Medical GmbH. The 510(k) number is K221949.

When did Ortho Device, ADAPTIX 3D Orthopedic Imaging System receive FDA 510(k) clearance?

Ortho Device, ADAPTIX 3D Orthopedic Imaging System received FDA 510(k) clearance on 2023-01-26, under 510(k) number K221949.

Who is the listed applicant for Ortho Device, ADAPTIX 3D Orthopedic Imaging System?

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

What is the FDA product code for Ortho Device, ADAPTIX 3D Orthopedic Imaging System?

The FDA product code for Ortho Device, ADAPTIX 3D Orthopedic Imaging System is IZF.

列明Pausch Medical 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。

K180651Uroview FD II K161019Uroview FD

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