FDA 510(k)

ETHICON Linx 食管测量工具

K号: K201035 · 2020-07-09

决定日期2020-07-09

产品代码QJN

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决定实质等同

器械摘要

ETHICON Linx Esophagus Sizing Tool is the device name listed in this FDA 510(k) record. The listed applicant is Torax Medical, Inc.. It received FDA 510(k) clearance on 2020-07-09 under 510(k) number K201035. The device is classified under product code QJN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ETHICON Linx Esophagus Sizing Tool?

ETHICON Linx Esophagus Sizing Tool is a medical device that received FDA 510(k) clearance on 2020-07-09. The listed applicant is Torax Medical, Inc.. The 510(k) number is K201035.

When did ETHICON Linx Esophagus Sizing Tool receive FDA 510(k) clearance?

ETHICON Linx Esophagus Sizing Tool received FDA 510(k) clearance on 2020-07-09, under 510(k) number K201035.

Who is the listed applicant for ETHICON Linx Esophagus Sizing Tool?

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

What is the FDA product code for ETHICON Linx Esophagus Sizing Tool?

The FDA product code for ETHICON Linx Esophagus Sizing Tool is QJN.

列明Torax 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。

K230089ETHICON LINX® 食管测量工具

官方来源

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