FDA 510(k)

萊曼測壓導管

K 號：K160170 · 2016-06-20

決定日期2016-06-20

產品代碼FFX

諮詢委員會GU

決定相當於

器材摘要

Lehman Manometry Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 2016-06-20 under 510(k) number K160170. The device is classified under product code FFX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Lehman Manometry Catheter?

Lehman Manometry Catheter is a medical device that received FDA 510(k) clearance on 2016-06-20. The listed applicant is Wilson-Cook Medical, Inc.. The 510(k) number is K160170.

When did Lehman Manometry Catheter receive FDA 510(k) clearance?

Lehman Manometry Catheter received FDA 510(k) clearance on 2016-06-20, under 510(k) number K160170.

Who is the listed applicant for Lehman Manometry Catheter?

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

What is the FDA product code for Lehman Manometry Catheter?

The FDA product code for Lehman Manometry Catheter is FFX.

其他以 Wilson-Cook 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。

K253302Hemospray內視鏡止血器（HEMO-[X])K243568Tesla雙極肛門切開器；Tesla BiCord活動繩 K213356Entuit PEG，Entuit PEGJ K212323Instinct Plus內視鏡夾合器 K201322恩圖伊特鼻腸管輸食管 K200972Hemospray內視鏡止血器

查看所有 32 項裝置 →

相關器械（代碼：FFX）

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。

K252605mcompass 直腸氣球排出針筒 (RMD-003-001)Medspira, LLC K240007太陽能精簡型（G4-1）Laborie Medical Technologies, Corp.K231861Endoflip™ 300 系統Covidien, LLC K223705Endoflip™ 300Covidien, LLC K222000通運-膠囊Medifactia AB K201106IntraMarX 3D 放射性不透明標記Anx Robotica Corp

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。