FDA 510(k)

沃尔特洛伦茨外科辅助臂内窥镜固定器

K号: K190576 · 2019-06-05

决定日期2019-06-05

产品代码OCV

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决定实质等同

器械摘要

WalterLorenz Surgical Assist Arm Scope Holder is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Microfixation. It received FDA 510(k) clearance on 2019-06-05 under 510(k) number K190576. The device is classified under product code OCV. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the WalterLorenz Surgical Assist Arm Scope Holder?

WalterLorenz Surgical Assist Arm Scope Holder is a medical device that received FDA 510(k) clearance on 2019-06-05. The listed applicant is Biomet Microfixation. The 510(k) number is K190576.

When did WalterLorenz Surgical Assist Arm Scope Holder receive FDA 510(k) clearance?

WalterLorenz Surgical Assist Arm Scope Holder received FDA 510(k) clearance on 2019-06-05, under 510(k) number K190576.

Who is the listed applicant for WalterLorenz Surgical Assist Arm Scope Holder?

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

What is the FDA product code for WalterLorenz Surgical Assist Arm Scope Holder?

The FDA product code for WalterLorenz Surgical Assist Arm Scope Holder is OCV.

列明Biomet Microfixation为申报人的其他记录

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