FDA 510(k)

SignalMark 肺活检位点标记

K号: K180175 · 2018-12-07

决定日期2018-12-07

产品代码GDW

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决定实质等同

器械摘要

SignalMark Lung Biopsy Site Marker is the device name listed in this FDA 510(k) record. The listed applicant is View Point Medical, Inc.. It received FDA 510(k) clearance on 2018-12-07 under 510(k) number K180175. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SignalMark Lung Biopsy Site Marker?

SignalMark Lung Biopsy Site Marker is a medical device that received FDA 510(k) clearance on 2018-12-07. The listed applicant is View Point Medical, Inc.. The 510(k) number is K180175.

When did SignalMark Lung Biopsy Site Marker receive FDA 510(k) clearance?

SignalMark Lung Biopsy Site Marker received FDA 510(k) clearance on 2018-12-07, under 510(k) number K180175.

Who is the listed applicant for SignalMark Lung Biopsy Site Marker?

The FDA 510(k) record lists View Point Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SignalMark Lung Biopsy Site Marker?

The FDA product code for SignalMark Lung Biopsy Site Marker is GDW.

列明View Point Medical, Inc.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。

K190689SignalMark 乳房标记

相关器械（代码：GDW）

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。

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