FDA 510(k)

ETHICON Linx 食管尺寸工具

K 號：K201035 · 2020-07-09

決定日期2020-07-09

產品代碼QJN

諮詢委員會GU

決定相當於

器材摘要

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.

常見問題

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.

其他以 Torax Medical, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K230089ETHICON LINX® 食管尺寸工具

相關器械（代碼：QJN）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K230089ETHICON LINX® 食管尺寸工具Torax Medical, Inc.

官方來源

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