FDA 510(k)

Tenex Health TX 系統

K 號：K153299 · 2016-03-03

決定日期2016-03-03

產品代碼LFL

決定相當於

器材摘要

Tenex Health TX System is the device name listed in this FDA 510(k) record. The listed applicant is Tenex Health, Inc.. It received FDA 510(k) clearance on 2016-03-03 under 510(k) number K153299. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

常見問題

What is the Tenex Health TX System?

Tenex Health TX System is a medical device that received FDA 510(k) clearance on 2016-03-03. The listed applicant is Tenex Health, Inc.. The 510(k) number is K153299.

When did Tenex Health TX System receive FDA 510(k) clearance?

Tenex Health TX System received FDA 510(k) clearance on 2016-03-03, under 510(k) number K153299.

Who is the listed applicant for Tenex Health TX System?

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

What is the FDA product code for Tenex Health TX System?

The FDA product code for Tenex Health TX System is LFL.

其他以 Tenex Health, 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。

K181367Tenex Health TX 系統搭配 TXP 微針

相關器械（代碼：LFL）

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。

K261448neXus 超聲外科吸引器系統Misonix, LLC K251162CUSA® 清晰度超聲手術吸引器系統Integra LifeSciences Corporation K242894SanAgile™ 超聲手術先進攜帶控制器 (SA10)；SanAgile™ 超聲手術先進解剖刀 (SASD14)；SanAgile™ 超聲手術先進解剖刀 (SASD23)；SanAgile™ 超聲手術先進解剖刀 (SASD36)；SanAgile™ 超聲手術先進解剖刀 (SASD45)Shanghai Saints Sages Surgical Co., Ltd.K243930Sonopet iQ 超聲吸引器系統 (5500-050-000)Stryker Instruments K241700Tenex 第二代系統Trice Medical, Inc.K240493CUSA® 清晰度超聲手術吸引器系統Integra LifeSciences Corporation

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。